Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Conditions
Keywords
Scintigraphy, Gammagraphy, TTR, ATTR, Hypertrophic cardiomyopathy (HCM), HCM
Brief summary
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) \>15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
Interventions
DIAGNOSTIC_TESTDiagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient signed inform consent. * Males and Females. * Age ≥50 years. * Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) ≥15mm in Echocardiogram. * Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.
Exclusion criteria
* Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR) * Severe aortic stenosis defined as aortic valve area (AVA) \< 1.0 cm2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life. |
| Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life. |
| Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life. |
| Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life. |
| Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags Electronic Case Report Form (e-CRF) part was considered as participants with a senso-motor polyneuropathy. |
| Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy. |
| Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy. |
| Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy. |
| Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS. |
| Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS. |
| Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS. |
| Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS. |
| Percentage of Participants With Autonomic Dysfunction: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes. |
| Percentage of Participants With Autonomic Dysfunction: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes. |
| Percentage of Participants With Autonomic Dysfunction: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes. |
| Percentage of Participants With Autonomic Dysfunction: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes. |
| Percentage of Participants With Cardiological Manifestations: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval less than (\<) 80 milliseconds (ms) or greater than (\>) 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2. |
| Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues. |
| Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues. |
| Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2) | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv. |
| Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3) | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv. |
| Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv. |
| Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv. |
| Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt. |
| Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt. |
| Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt. |
| Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt. |
| Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure. |
| Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure. |
| Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure. |
| Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants With TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure. |
| Percentage of Participants With Cardiological Manifestations: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2. |
| Percentage of Participants With Cardiological Manifestations: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2. |
| Percentage of Participants With Cardiological Manifestations: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2. |
| Percentage of Participants With Laboratory Abnormalities: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Laboratory parameters that were considered as out of range included creatinine \<45 micromole per liter (μmol/L) or greater than 104 μmol/L w; haemoglobin, participants with a value lower than 11.5 grams per deciliter (g/dL) or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 picograms per milliliter (pg/mL); N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL. |
| Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants who used pacemaker and ICD were reported in this outcome measure. |
| Percentage of Participants With Laboratory Abnormalities: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL. |
| Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL. |
| Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL. |
| Number of Participants According to Presence of Neurological Red Flag: FAS1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of neurological red flag as 'Yes' or 'No'. |
| Number of Participants According to Presence of Neurological Red Flag: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of neurological red flag as 'Yes' or 'No'. |
| Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Grade of scintigraphy evaluated by the investigator and Grade of SPECT: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone. Only categories with non-zero values were reported. |
| Cardiological Assessments - Blood Pressure: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated. |
| Cardiological Assessments - Blood Pressure: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | SBP and DBP were evaluated. |
| Cardiological Assessments - Blood Pressure: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | SBP and DBP were evaluated. |
| Cardiological Assessments - Blood Pressure: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | SBP and DBP were evaluated. |
| Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Baseline | Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence. |
| Heart Rate Parameter for Participants Without Paced: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Baseline | Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence. |
| Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Baseline | Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence. |
| Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Baseline | Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence. |
| Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants. |
| Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants. |
| Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants. |
| Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants. |
| Number of Participants With Atrial Fibrillation Assessment: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure. |
| Number of Participants With Atrial Fibrillation Assessment: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure. |
| Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure. |
| Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure. |
| Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants who used pacemaker and ICD were reported in this outcome measure. |
| Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants who used pacemaker and ICD were reported in this outcome measure. |
| Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants who used pacemaker and ICD were reported in this outcome measure. |
| Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space. |
| Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space. |
| Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space. |
| Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space. |
| Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure. |
| Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure. |
| Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure. |
| Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure. |
| Heart Rate Parameter for Participants Without Paced: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Heart Rate Parameter for Participants Without Paced: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Heart Rate Parameter for Participants Without Paced: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Sokolow Index: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy. |
| Sokolow Index: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy. |
| Sokolow Index: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy. |
| Sokolow Index: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy. |
| Left Ventricular Ejection Fraction (LVEF): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage. |
| Left Ventricular Ejection Fraction (LVEF): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage. |
| Left Ventricular Ejection Fraction (LVEF): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage. |
| Left Ventricular Ejection Fraction (LVEF): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage. |
| Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT. |
| Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT. |
| Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT. |
| Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT. |
| Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to strain apical preserved as 'No' and 'Yes'. |
| Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to strain apical preserved as 'No' and 'Yes'. |
| Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to strain apical preserved as 'No' and 'Yes'. |
| Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to strain apical preserved as 'No' and 'Yes'. |
| LV End Diastolic Diameter: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Left ventricular end-diastolic diameter (LVEDD) reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency. |
| LV End Diastolic Diameter: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency. |
| LV End Diastolic Diameter: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency. |
| LV End Diastolic Diameter: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency. |
| Maximum Wall Thickness: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Maximum Wall Thickness: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a left ventricular (LV) wall thickness greater than or equal to (\>=) 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life. |
| Maximum Wall Thickness: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
| Number of Participants According to Type of Hypertrophic Pattern: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix. |
| Number of Participants According to Type of Hypertrophic Pattern: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix. |
| Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix. |
| Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix. |
| LV Mass Index (LVMI): FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area. |
| LV Mass Index (LVMI): FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area. |
| LV Mass Index (LVMI): FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area. |
| LV Mass Index (LVMI): FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area. |
| Aortic Valvular Stenosis - Aortic Valve Area: FAS 2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure. |
| Aortic Valvular Stenosis - Aortic Valve Area: FAS 3 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure. |
| Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure. |
| Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure. |
| Maximum Wall Thickness: FAS 3.1 | During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years) | — |
Countries
Australia, Austria, France, Italy, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom
Participant flow
Recruitment details
Data of participants diagnosed with left ventricular hypertrophy (LVH) confirmed by bone scintigraphy and/or single photon emission computed tomography (SPECT) and greater than or equal to (\>=) 50 years of age were observed in this study.
Pre-assignment details
Data from eligible participants were retrieved and observed from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years).
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included. | 766 |
| Total | 766 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria (age less than 50 years) | 2 |
| Overall Study | Scintigraphy was not performed | 44 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 72.3 Years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized African | 21 Participants |
| Race/Ethnicity, Customized Asian | 27 Participants |
| Race/Ethnicity, Customized Caucasian | 665 Participants |
| Race/Ethnicity, Customized Caucasian & Portuguese (or Portuguese parents) | 47 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Sex: Female, Male Female | 233 Participants |
| Sex: Female, Male Male | 533 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1 | 32.0 Percentage of participants |
Secondary
Aortic Valvular Stenosis - Aortic Valve Area: FAS 2
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Valvular Stenosis - Aortic Valve Area: FAS 2 | 2.3 Centimeter square | Standard Deviation 0.8 |
Secondary
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Valvular Stenosis - Aortic Valve Area: FAS 3 | 2.2 Centimeter square | Standard Deviation 0.7 |
Secondary
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1 | 2.3 Centimeter square | Standard Deviation 0.7 |
Secondary
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2
Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2 | 2.0 Centimeter square | Standard Deviation 0.7 |
Secondary
Cardiological Assessments - Blood Pressure: FAS 2
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Cardiological Assessments - Blood Pressure: FAS 2 | DBP | 75.6 mmHg | Standard Deviation 12.4 |
| All Participants | Cardiological Assessments - Blood Pressure: FAS 2 | SBP | 132.5 mmHg | Standard Deviation 20 |
Secondary
Cardiological Assessments - Blood Pressure: FAS 3
SBP and DBP were evaluated.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3 | DBP | 74.6 mmHg | Standard Deviation 12 |
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3 | SBP | 131.0 mmHg | Standard Deviation 19 |
Secondary
Cardiological Assessments - Blood Pressure: FAS 3.1
SBP and DBP were evaluated.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3.1 | DBP | 75.6 mmHg | Standard Deviation 11.8 |
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3.1 | SBP | 130.9 mmHg | Standard Deviation 18.1 |
Secondary
Cardiological Assessments - Blood Pressure: FAS 3.2
SBP and DBP were evaluated.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3.2 | DBP | 74.2 mmHg | Standard Deviation 11.9 |
| All Participants | Cardiological Assessments - Blood Pressure: FAS 3.2 | SBP | 131.9 mmHg | Standard Deviation 20.5 |
Secondary
Heart Rate Parameter for Participants Without Paced: FAS 2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Heart Rate Parameter for Participants Without Paced: FAS 2 | 73.3 Beats per minute | Standard Deviation 15.1 |
Secondary
Heart Rate Parameter for Participants Without Paced: FAS 3
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Heart Rate Parameter for Participants Without Paced: FAS 3 | 73.2 Beats per minute | Standard Deviation 14.7 |
Secondary
Heart Rate Parameter for Participants Without Paced: FAS 3.1
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Heart Rate Parameter for Participants Without Paced: FAS 3.1 | 73.4 Beats per minute | Standard Deviation 15.9 |
Secondary
Heart Rate Parameter for Participants Without Paced: FAS 3.2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Heart Rate Parameter for Participants Without Paced: FAS 3.2 | 72.7 Beats per minute | Standard Deviation 12.1 |
Secondary
Left Ventricular Ejection Fraction (LVEF): FAS 2
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Left Ventricular Ejection Fraction (LVEF): FAS 2 | 55.0 Percentage of blood volume | Standard Deviation 11.4 |
Secondary
Left Ventricular Ejection Fraction (LVEF): FAS 3
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Left Ventricular Ejection Fraction (LVEF): FAS 3 | 55.2 Percentage of blood volume | Standard Deviation 11.2 |
Secondary
Left Ventricular Ejection Fraction (LVEF): FAS 3.1
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Left Ventricular Ejection Fraction (LVEF): FAS 3.1 | 55.7 Percentage of blood volume | Standard Deviation 11.2 |
Secondary
Left Ventricular Ejection Fraction (LVEF): FAS 3.2
LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Left Ventricular Ejection Fraction (LVEF): FAS 3.2 | 53.9 Percentage of blood volume | Standard Deviation 11.4 |
Secondary
LV End Diastolic Diameter: FAS 2
Left ventricular end-diastolic diameter (LVEDD) reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV End Diastolic Diameter: FAS 2 | 43.3 Millimeter | Standard Deviation 7.9 |
Secondary
LV End Diastolic Diameter: FAS 3
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV End Diastolic Diameter: FAS 3 | 43.2 Millimeter | Standard Deviation 7.9 |
Secondary
LV End Diastolic Diameter: FAS 3.1
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV End Diastolic Diameter: FAS 3.1 | 43.2 Millimeter | Standard Deviation 7.5 |
Secondary
LV End Diastolic Diameter: FAS 3.2
LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV End Diastolic Diameter: FAS 3.2 | 44.4 Millimeter | Standard Deviation 6.8 |
Secondary
LV Mass Index (LVMI): FAS 2
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV Mass Index (LVMI): FAS 2 | 172.7 Grams per meter square | Standard Deviation 64 |
Secondary
LV Mass Index (LVMI): FAS 3
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV Mass Index (LVMI): FAS 3 | 177.0 Grams per meter square | Standard Deviation 53.2 |
Secondary
LV Mass Index (LVMI): FAS 3.1
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV Mass Index (LVMI): FAS 3.1 | 177.0 Grams per meter square | Standard Deviation 48.7 |
Secondary
LV Mass Index (LVMI): FAS 3.2
Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | LV Mass Index (LVMI): FAS 3.2 | 185.5 Grams per meter square | Standard Deviation 62 |
Secondary
Maximum Wall Thickness: FAS 2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Maximum Wall Thickness: FAS 2 | 17.4 Millimeter | Standard Deviation 2.5 |
Secondary
Maximum Wall Thickness: FAS 3
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Maximum Wall Thickness: FAS 3 | 17.5 Millimeter | Standard Deviation 2.4 |
Secondary
Maximum Wall Thickness: FAS 3.1
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Maximum Wall Thickness: FAS 3.1 | 17.9 Millimeter | Standard Deviation 2.5 |
Secondary
Maximum Wall Thickness: FAS 3.2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Maximum Wall Thickness: FAS 3.2 | 16.9 Millimeter | Standard Deviation 2.2 |
Secondary
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 | No | 217 Participants |
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 | Yes | 18 Participants |
Secondary
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 | No | 182 Participants |
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 | Yes | 18 Participants |
Secondary
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 | No | 122 Participants |
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 | Yes | 10 Participants |
Secondary
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2
Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 | No | 49 Participants |
| All Participants | Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 | Yes | 6 Participants |
Secondary
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1
Grade of scintigraphy evaluated by the investigator and Grade of SPECT: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone. Only categories with non-zero values were reported.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | Investigator: Grade 0; SPECT: Grade 0 | 43 Participants |
| All Participants | Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | Investigator: Grade 0; SPECT: Grade 1 | 3 Participants |
| All Participants | Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | Investigator: Grade 1; SPECT: Grade 1 | 5 Participants |
| All Participants | Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | Investigator: Grade 2; SPECT: Grade 2 | 16 Participants |
| All Participants | Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 | Investigator: Grade 3; SPECT: Grade 3 | 8 Participants |
Secondary
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Time frame: Baseline
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Carpal tunnel syndrome | Yes | 81 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Renal insufficiency | Yes | 68 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Diabetes Mellitus | No | 193 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Diabetes Mellitus | Yes | 52 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Lumbar spinal stenosis | No | 221 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Lumbar spinal stenosis | Yes | 24 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Carpal tunnel syndrome | No | 164 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Diagnosed hypertension | No | 78 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Diagnosed hypertension | Yes | 167 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Antihypertensive medication | No | 89 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Antihypertensive medication | Yes | 156 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Coronary artery disease | No | 184 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Coronary artery disease | Yes | 61 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 | Renal insufficiency | No | 177 Participants |
Secondary
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Time frame: Baseline
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Diagnosed hypertension | No | 77 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Diagnosed hypertension | Yes | 131 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Antihypertensive medication | No | 88 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Antihypertensive medication | Yes | 120 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Coronary artery disease | No | 162 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Coronary artery disease | Yes | 46 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Renal insufficiency | No | 147 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Diabetes Mellitus | Yes | 33 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Lumbar spinal stenosis | No | 184 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Lumbar spinal stenosis | Yes | 24 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Carpal tunnel syndrome | No | 130 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Carpal tunnel syndrome | Yes | 78 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Renal insufficiency | Yes | 61 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 | Diabetes Mellitus | No | 175 Participants |
Secondary
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Time frame: Baseline
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Diagnosed hypertension | No | 49 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Diagnosed hypertension | Yes | 88 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Antihypertensive medication | No | 57 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Antihypertensive medication | Yes | 80 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Coronary artery disease | No | 112 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Coronary artery disease | Yes | 25 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Renal insufficiency | No | 102 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Renal insufficiency | Yes | 35 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Diabetes Mellitus | No | 118 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Diabetes Mellitus | Yes | 19 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Lumbar spinal stenosis | No | 121 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Lumbar spinal stenosis | Yes | 16 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Carpal tunnel syndrome | No | 80 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 | Carpal tunnel syndrome | Yes | 57 Participants |
Secondary
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2
Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.
Time frame: Baseline
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Diagnosed hypertension | No | 19 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Diagnosed hypertension | Yes | 37 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Antihypertensive medication | No | 22 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Antihypertensive medication | Yes | 34 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Coronary artery disease | No | 43 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Coronary artery disease | Yes | 13 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Renal insufficiency | No | 35 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Renal insufficiency | Yes | 21 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Diabetes Mellitus | No | 45 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Diabetes Mellitus | Yes | 11 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Lumbar spinal stenosis | No | 50 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Lumbar spinal stenosis | Yes | 6 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Carpal tunnel syndrome | No | 37 Participants |
| All Participants | Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 | Carpal tunnel syndrome | Yes | 19 Participants |
Secondary
Number of Participants According to Presence of Neurological Red Flag: FAS1
Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Presence of Neurological Red Flag: FAS1 | Yes | 143 Participants |
| All Participants | Number of Participants According to Presence of Neurological Red Flag: FAS1 | No | 623 Participants |
Secondary
Number of Participants According to Presence of Neurological Red Flag: FAS 2
Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Presence of Neurological Red Flag: FAS 2 | Yes | 142 Participants |
| All Participants | Number of Participants According to Presence of Neurological Red Flag: FAS 2 | No | 103 Participants |
Secondary
Number of Participants According to Type of Hypertrophic Pattern: FAS 2
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 2 | Apical | 6 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 2 | Concentric | 179 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 2 | Asymmetric | 47 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 2 | Mix | 8 Participants |
Secondary
Number of Participants According to Type of Hypertrophic Pattern: FAS 3
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3 | Apical | 4 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3 | Concentric | 159 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3 | Asymmetric | 37 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3 | Mix | 4 Participants |
Secondary
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 | Apical | 1 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 | Concentric | 105 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 | Asymmetric | 27 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 | Mix | 2 Participants |
Secondary
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2
Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 | Apical | 2 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 | Concentric | 46 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 | Asymmetric | 7 Participants |
| All Participants | Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 | Mix | 1 Participants |
Secondary
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 | No | 215 Participants |
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 | Yes | 26 Participants |
Secondary
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 | No | 183 Participants |
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 | Yes | 22 Participants |
Secondary
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 | No | 119 Participants |
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 | Yes | 17 Participants |
Secondary
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2
LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 | No | 51 Participants |
| All Participants | Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 | Yes | 5 Participants |
Secondary
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 | No | 86 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 | Yes | 135 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 | Missing | 6 Participants |
Secondary
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 | No | 72 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 | Yes | 114 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 | Missing | 4 Participants |
Secondary
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 | No | 51 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 | Yes | 73 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 | Missing | 3 Participants |
Secondary
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 | No | 18 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 | Yes | 32 Participants |
| All Participants | Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 | Missing | 0 Participants |
Secondary
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 | No | 28 Participants |
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 | Yes | 62 Participants |
Secondary
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 | No | 26 Participants |
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 | Yes | 60 Participants |
Secondary
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 | No | 16 Participants |
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 | Yes | 46 Participants |
Secondary
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2
Participants were classified according to strain apical preserved as 'No' and 'Yes'.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 | No | 8 Participants |
| All Participants | Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 | Yes | 12 Participants |
Secondary
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | Class III | 57 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | Missing data | 1 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | Class I | 50 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | Class II | 130 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 | Class IV | 7 Participants |
Secondary
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | Class I | 45 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | Class II | 112 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | Class III | 45 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | Class IV | 5 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 | Missing data | 1 Participants |
Secondary
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | Class I | 34 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | Class II | 69 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | Class III | 30 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | Class IV | 3 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 | Missing data | 1 Participants |
Secondary
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2
Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 | Class I | 5 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 | Class II | 38 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 | Class III | 11 Participants |
| All Participants | Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 | Class IV | 2 Participants |
Secondary
Number of Participants With Atrial Fibrillation Assessment: FAS 2
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 2 | No | 120 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 2 | Yes permanent | 90 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 2 | Yes in the past | 35 Participants |
Secondary
Number of Participants With Atrial Fibrillation Assessment: FAS 3
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3 | No | 105 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3 | Yes permanent | 78 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3 | Yes in the past | 25 Participants |
Secondary
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 | No | 65 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 | Yes permanent | 52 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 | Yes in the past | 20 Participants |
Secondary
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2
Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 | No | 28 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 | Yes permanent | 23 Participants |
| All Participants | Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 | Yes in the past | 5 Participants |
Secondary
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 | Positive | 55 Participants |
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 | Negative | 11 Participants |
Secondary
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 | Negative | 7 Participants |
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 | Positive | 50 Participants |
Secondary
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 | Negative | 6 Participants |
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 | Positive | 33 Participants |
Secondary
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2
Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 | Negative | 0 Participants |
| All Participants | Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 | Positive | 13 Participants |
Secondary
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2
Participants who used pacemaker and ICD were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 | Pacemaker | Yes | 30 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 | Pacemaker | No | 215 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 | ICD | Yes | 0 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 | ICD | No | 245 Participants |
Secondary
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3
Participants who used pacemaker and ICD were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 | Pacemaker | Yes | 30 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 | Pacemaker | No | 178 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 | ICD | Yes | 0 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 | ICD | No | 208 Participants |
Secondary
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1
Participants who used pacemaker and ICD were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 | Pacemaker | Yes | 20 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 | Pacemaker | No | 117 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 | ICD | Yes | 0 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 | ICD | No | 137 Participants |
Secondary
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2
Participants who used pacemaker and ICD were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 | Pacemaker | Yes | 7 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 | Pacemaker | No | 49 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 | ICD | Yes | 0 Participants |
| All Participants | Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 | ICD | No | 56 Participants |
Secondary
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2 | 13 Participants |
Secondary
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3 | 13 Participants |
Secondary
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1 | 11 Participants |
Secondary
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants With TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2 | 2 Participants |
Secondary
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a left ventricular (LV) wall thickness greater than or equal to (\>=) 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1 | 17.1 Percentage of participants |
Secondary
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2 | 11.8 Percentage of participants |
Secondary
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3 | 9.6 Percentage of participants |
Secondary
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1 | 10.9 Percentage of participants |
Secondary
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2
Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2 | 7.1 Percentage of participants |
Secondary
Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1
Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1 | 25.2 Percentage of participants |
Secondary
Percentage of Participants With Autonomic Dysfunction: FAS 2
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Autonomic Dysfunction: FAS 2 | 55.9 Percentage of participants |
Secondary
Percentage of Participants With Autonomic Dysfunction: FAS 3
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Autonomic Dysfunction: FAS 3 | 58.7 Percentage of participants |
Secondary
Percentage of Participants With Autonomic Dysfunction: FAS 3.1
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Autonomic Dysfunction: FAS 3.1 | 61.3 Percentage of participants |
Secondary
Percentage of Participants With Autonomic Dysfunction: FAS 3.2
Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = Yes.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Autonomic Dysfunction: FAS 3.2 | 57.1 Percentage of participants |
Secondary
Percentage of Participants With Cardiological Manifestations: FAS 2
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval less than (\<) 80 milliseconds (ms) or greater than (\>) 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Cardiological Manifestations: FAS 2 | 98.0 Percentage of participants |
Secondary
Percentage of Participants With Cardiological Manifestations: FAS 3
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Cardiological Manifestations: FAS 3 | 98.1 Percentage of participants |
Secondary
Percentage of Participants With Cardiological Manifestations: FAS 3.1
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Cardiological Manifestations: FAS 3.1 | 97.8 Percentage of participants |
Secondary
Percentage of Participants With Cardiological Manifestations: FAS 3.2
Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Cardiological Manifestations: FAS 3.2 | 98.2 Percentage of participants |
Secondary
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2 | 48.6 Percentage of participants |
Secondary
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3 | 54.8 Percentage of participants |
Secondary
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1 | 60.6 Percentage of participants |
Secondary
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2
CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2 | 48.2 Percentage of participants |
Secondary
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1 | 8.7 Percentage of participants |
Secondary
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2 | 3.7 Percentage of participants |
Secondary
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2) | 6.5 Percentage of participants |
Secondary
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3) | 6.9 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities: FAS 2
Laboratory parameters that were considered as out of range included creatinine \<45 micromole per liter (μmol/L) or greater than 104 μmol/L w; haemoglobin, participants with a value lower than 11.5 grams per deciliter (g/dL) or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 picograms per milliliter (pg/mL); N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 2 | Creatinine out of range | 37.6 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 2 | Haemoglobin out of range | 30.2 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 2 | BNP out of range | 62.9 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 2 | NTproBNP out of range | 81.2 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 2 | Troponin I out of range | 3.7 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities: FAS 3
Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3 | Creatinine out of range | 42.3 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3 | Haemoglobin out of range | 33.2 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3 | BNP out of range | 69.7 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3 | NTproBNP out of range | 88.9 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3 | Troponin I out of range | 3.8 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities: FAS 3.1
Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | Creatinine out of range | 34.3 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | Haemoglobin out of range | 34.3 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | BNP out of range | 68.6 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | NTproBNP out of range | 90.5 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.1 | Troponin I out of range | 4.4 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities: FAS 3.2
Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | Creatinine out of range | 58.9 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | Haemoglobin out of range | 35.7 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | BNP out of range | 89.3 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | NTproBNP out of range | 98.2 Percentage of participants |
| All Participants | Percentage of Participants With Laboratory Abnormalities: FAS 3.2 | Troponin I out of range | 1.8 Percentage of participants |
Secondary
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags Electronic Case Report Form (e-CRF) part was considered as participants with a senso-motor polyneuropathy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2 | 80.0 Percentage of participants |
Secondary
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3 | 86.1 Percentage of participants |
Secondary
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1 | 89.8 Percentage of participants |
Secondary
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2
Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2 | 85.7 Percentage of participants |
Secondary
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1 | 17.9 Percentage of participants |
Secondary
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2 | 93.5 Percentage of participants |
Secondary
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3 | 93.1 Percentage of participants |
Secondary
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1 | 91.3 Percentage of participants |
Secondary
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2 | 96.3 Percentage of participants |
Secondary
Sokolow Index: FAS 2
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Sokolow Index: FAS 2 | 19.1 Millimeter | Standard Deviation 8.8 |
Secondary
Sokolow Index: FAS 3
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Sokolow Index: FAS 3 | 18.7 Millimeter | Standard Deviation 8.6 |
Secondary
Sokolow Index: FAS 3.1
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Sokolow Index: FAS 3.1 | 19.8 Millimeter | Standard Deviation 8.7 |
Secondary
Sokolow Index: FAS 3.2
Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Sokolow Index: FAS 3.2 | 16.5 Millimeter | Standard Deviation 8.4 |