Heart Failure
Conditions
Keywords
Heart failure with preserved ejection fraction (HFpEF), Heart failure with reduced ejection fraction (HFrEF)
Brief summary
The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.
Detailed description
Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)
Interventions
DEVICEAVIVO Mobile Patient Management (MPM) System
Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
DEVICEVitalPatch biosensor
Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
DEVICEDynaPort Move Monitor
Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent signed before any study-specific procedure * Men or women aged 45 years and older * Established diagnosis of chronic heart failure NYHA class II-IV * Worsening heart failure requiring hospitalization for the initiation of intensification of heart failure therapy with at least one of the following: a) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) OR BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation); OR b) Radiographic evidence of pulmonary congestion (interstitial edema, pulmonary venous hypertension, vascular congestion, pleural effusion); OR c) Catheterization documented elevated filling pressures at rest (left ventricular end-diastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure ≥ 20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥ 25 mmHg) OR Ambulatory patients with a history of heart failure on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks and at least one of the following: a) Hospitalization for heart failure within the past 12 months; OR b) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) or BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation) * For HFrEF only: EF ≤35% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion * For HFpEF only: EF ≥45% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion * Willingness to wear the DynaPort Move Monitor accelerometer belt and VitalPatch Biosensor during the trial * Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process
Exclusion criteria
* Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection, and attending required follow up study visits * Hemoglobin \< 8.0 g/dl * Acute coronary syndrome or percutaneous coronary intervention within 3 months prior to informed consent * Listing for heart transplantation and / or anticipated implantation of a ventricular assist device * Inability to exercise: wheelchair / scooter / walker dependent; dependent on supplemental oxygen * Known clinically significant persistent coronary ischemia (based on medical history, a preexisting or a recent clinical stress test) * HF is not the primary factor limiting activity within the last three months as indicated by the patient affirming #1, #2 or #3 of the following questionnaire: My ability to be active is most limited by: #1 - Joint, foot, leg, hip or back pain; #2 - Unsteadiness or dizziness impairing daily mobility; #3 - Lifestyle, weather, or I just don't like to be active * Occurrence of any of the following within 3 months prior to informed consent: Myocardial infarction, Hospitalization for unstable angina, Stroke or transient ischemic attack, Coronary artery bypass graft (CABG), Percutaneous coronary intervention (PCI), Implantation of a cardiac resynchronization therapy device (CRTD), Major surgery (that could interfere with patients' ability to exercise) * PCI, CABG or implantation of a CRTD planned between randomization and Visit 4 * Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG lead II orientation) * Subject with known allergies or hypersensitivities to adhesives or hydrogels * Severe uncorrected valvular heart disease * Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation) * Severe pulmonary disease with any of the following: Requirement of continuous (home) oxygen or History of chronic obstructive pulmonary disease ≥ GOLD III * Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s) * Any condition or therapy, which would make the patient unsuitable for the study, or life expectancy less than 12 months (e.g. active malignancy) * Heavy alcohol consumption or the use of illicit drugs that, in the opinion of the investigator, may interfere with the patient's safety and / or compliance * Patients who regularly (\> 1x per week) swim, do water aerobics or go to the sauna, unwilling to omit this activity while needing to wear the study specific medical devices * Active myocarditis * Primary hypertrophic cardiomyopathy * Constrictive pericarditis or pericardial tamponade * Close affiliation with the investigational site, e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) * Previous participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Daily Physical Activity Measured With VitalPatch Biosensor | Up to Day 84 | Intensity of daily physical activity was collected and measured with VitalPatch biosensor. |
| Daily Steps Count | At Day 9 and Day 77 | Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. |
| Daily Physical Activity Level | At Day 9 and Day 77 | Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity. |
| Total Daily Energy Expenditure | At Day 9 and Day 77 | Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. |
| Duration of Daily Physical Activity | At Day 9 and Day 77 | Duration of daily physical activity was measured with DynaPort Move Monitor device. |
| Time Duration Per Activity Status | At Day 9 and Day 77 | Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more. |
| Amount of Daily Physical Activity Measured With VitalPatch Biosensor | Up to Day 84 | Amount of daily physical activity was collected and measured with VitalPatch biosensor. |
| Duration of Daily Physical Activity Measured With VitalPatch Biosensor | Up to Day 84 | Duration of daily physical activity was collected and measured with VitalPatch biosensor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured With the PRO - Activity Scores | At Day 9 and Day 77 | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states. |
| Quality of Life as Measured With the PRO - Change in Activities and Symptoms | At Day 9 and Day 77 | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question How have your physical activities changed since you were discharged from the hospital: 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions How has your feeling of tiredness changed since you were discharged from the hospital, How has your shortness of breath changed since you were discharged from the hospital and How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital: 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. |
| Copeptin | At Day 9 and Day 84 | Blood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. |
| Galectin-3 | At Day 9 and Day 84 | Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. |
| Growth Differentiation Factor 15 (GDF 15) | At Day 9 and Day 84 | Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. |
| Human Interleukin-1 Receptor 4 / ST2 (sST2) | At Day 9 and Day 84 | Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0) |
| Human Insulin-like Growth Factor Binding (IGFBP7) | At Day 9 and Day 84 | Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. |
| Heart Rate Variability (HRV) Derived From ECG | Up to Day 84 | Heart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensor |
| N-terminal Propeptide of BNP (NT-proBNP) | At Day 9 and Day 84 | Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. |
| High Sensitive Troponin T (hsTRT) | At Day 9 and Day 84 | Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0) |
| Blood Pressure | At Day 9, Day 77 and Day 84 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected. |
| Heart Rate | At Day 9, Day 77 and Day 84 | Heart rate data were collected by electrocardiogram (ECG). |
| Interventricular Septal Wall Thickness | At Day 84 | Interventricular septal wall thickness was measured by echocardiography. |
| Diameter of the Left Ventricle in Diastole | At Day 84 | Diameter of the left ventricle in diastole was measured by echocardiography. |
| Diameter of the Left Ventricle in Systole | At Day 84 | Diameter of the left ventricle in systole was measured by echocardiography. |
| Left Ventricular End-diastolic Volume | At Day 84 | Left ventricular end-diastolic volume was measured by echocardiography. |
| Left Ventricular End-systolic Volume | At Day 84 | Left ventricular end-systolic volume was measured by echocardiography. |
| Left Ventricular Ejection Fraction | At Day 84 | Left ventricular ejection fraction was measured by echocardiography. |
| Left Atrial End Systolic Volume Index | At Day 84 | Left atrial end systolic volume index was measured by echocardiography. |
| Mitral Peak Velocity of Early Filling (E) | At Day 84 | Mitral peak velocity of early filling (E) was measured by echocardiography. |
| Mitral Peak Velocity of Late Filling (A) | At Day 84 | Mitral peak velocity of late filling (A) was measured by echocardiography. |
| Mitral Lateral Annulus Early Diastolic Peak Velocity | At Day 84 | Mitral lateral annulus early diastolic peak velocity was measured by echocardiography. |
| Mitral Septal Annulus Early Diastolic Peak Velocity | At Day 84 | Mitral septal annulus early diastolic peak velocity was measured by echocardiography. |
| Tricuspid Annular Plane Systolic Excursion | At Day 84 | Tricuspid annular plane systolic excursion was measured by echocardiography. |
| Number of Participants Per NYHA Classification by Visit | At Day 9 and Day 84 | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. 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, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
| Left Atrial End-systolic Volume | At Day 84 | Left atrial end-systolic volume was measured by echocardiography. |
| 6-minute Walking Distance (6MWD) | At Day 84 | 6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. |
| Sleep Movements | Up to Day 84 | Sleep movements was measured with DynaPort Move Monitor device. |
| Sleep Patterns | Up to Day 84 | Sleep patterns was measured with DynaPort Move Monitor device. |
| Sit-to-stand Behaviour | Up to Day 84 | Sit-to-stand behaviour was measured with DynaPort Move Monitor device. |
| Pressure Gradient of Tricuspid Valve | At Day 84 | Pressure gradient of tricuspid valve was measured by echocardiography. |
| Right Atrial Mean Pressure | At Day 84 | Right atrial mean pressure was measured by echocardiography. |
| Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | At Day 9 and Day 84 | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients' HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From signing the ICF until follow-up visit (up to 7 months) | An adverse event (AE) was any untoward medical occurrence in a participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by the investigator. |
Countries
Germany, Italy, United States
Participant flow
Recruitment details
The study was conducted at multiple centers in 3 countries between 06 APR 2018 (first participant first visit) and 12 MAR 2021 (last participant last visit).
Pre-assignment details
Overall, 29 participants were screened, of which 2 participants were screening failures and 27 participants received at least one device.
Participants by arm
| Arm | Count |
|---|---|
| HFrEF Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. | 14 |
| HFpEF Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | HFrEF | Total | HFpEF |
|---|---|---|---|
| 6-minute walking distance (6MWD) | 382 Meters (m) | 337 Meters (m) | 291 Meters (m) |
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 9.2 | 69.1 Years STANDARD_DEVIATION 10 | 73.8 Years STANDARD_DEVIATION 8.9 |
| Blood pressure DBP | 69.3 millimetre of mercury (mmHg) STANDARD_DEVIATION 11.9 | 67.7 millimetre of mercury (mmHg) STANDARD_DEVIATION 11.7 | 66.3 millimetre of mercury (mmHg) STANDARD_DEVIATION 12 |
| Blood pressure SBP | 114.0 millimetre of mercury (mmHg) STANDARD_DEVIATION 17.6 | 119.2 millimetre of mercury (mmHg) STANDARD_DEVIATION 16.9 | 124.0 millimetre of mercury (mmHg) STANDARD_DEVIATION 15.5 |
| Copeptin | 47.047 Picomoles per litre (pmol/L) STANDARD_DEVIATION 37.744 | 39.755 Picomoles per litre (pmol/L) STANDARD_DEVIATION 31.96 | 31.551 Picomoles per litre (pmol/L) STANDARD_DEVIATION 23.693 |
| Diameter of the left ventricle in diastole | 64.085 Millimeters (mm) STANDARD_DEVIATION 7.074 | 57.252 Millimeters (mm) STANDARD_DEVIATION 10.271 | 48.369 Millimeters (mm) STANDARD_DEVIATION 6.001 |
| Diameter of the left ventricle in systole | 55.278 Millimeters (mm) STANDARD_DEVIATION 7.119 | 44.028 Millimeters (mm) STANDARD_DEVIATION 12.906 | 32.778 Millimeters (mm) STANDARD_DEVIATION 4.302 |
| Galectin-3 | 15.622 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 9.403 | 14.042 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 7.621 | 12.265 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 4.988 |
| Growth differentiation factor 15 (GDF 15) | 4740.2 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 4840 | 3775.2 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 3718.5 | 2689.6 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 1512.6 |
| Heart rate | 69.5 Beats per minute STANDARD_DEVIATION 12.8 | 74.3 Beats per minute STANDARD_DEVIATION 15.5 | 78.7 Beats per minute STANDARD_DEVIATION 17 |
| High sensitive Troponin T | 58.58 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 46.3 | 42.89 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 38.74 | 22.73 Picograms per millilitre (pg/mL) STANDARD_DEVIATION 6.99 |
| Human Insulin-like Growth Factor Binding | 311.6 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 241 | 305.5 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 207.8 | 289.0 Nanograms per milliliter (ng/mL) STANDARD_DEVIATION 109.7 |
| Human interleukin-1 Receptor 4 / ST2 | 35.09 Picograms per litre (pg/L) STANDARD_DEVIATION 14.33 | 32.08 Picograms per litre (pg/L) STANDARD_DEVIATION 16.2 | 28.69 Picograms per litre (pg/L) STANDARD_DEVIATION 18.45 |
| Interventricular septal wall thickness | 10.377 Millimeters (mm) STANDARD_DEVIATION 3.178 | 11.138 Millimeters (mm) STANDARD_DEVIATION 2.589 | 11.974 Millimeters (mm) STANDARD_DEVIATION 1.478 |
| Left atrial end-systolic volume | 115.708 Milliliter (mL) STANDARD_DEVIATION 56.175 | 104.954 Milliliter (mL) STANDARD_DEVIATION 47.959 | 86.517 Milliliter (mL) STANDARD_DEVIATION 22.065 |
| Left atrial end systolic volume index | 60.4508 Milliliter per square meter (mL/m^2) STANDARD_DEVIATION 33.8365 | 54.6017 Milliliter per square meter (mL/m^2) STANDARD_DEVIATION 28.7688 | 44.5747 Milliliter per square meter (mL/m^2) STANDARD_DEVIATION 14.0789 |
| Left ventricular ejection fraction | 28.54 Percentage of the volumn of blood STANDARD_DEVIATION 6.83 | 39.42 Percentage of the volumn of blood STANDARD_DEVIATION 14.11 | 53.56 Percentage of the volumn of blood STANDARD_DEVIATION 5.58 |
| Left ventricular end-diastolic volume | 224.480 Milliliter (mL) STANDARD_DEVIATION 42.473 | 169.042 Milliliter (mL) STANDARD_DEVIATION 77.285 | 89.846 Milliliter (mL) STANDARD_DEVIATION 27.972 |
| Left ventricular end-systolic volume | 151.61 Milliliter (mL) STANDARD_DEVIATION 32.46 | 108.78 Milliliter (mL) STANDARD_DEVIATION 61.37 | 41.49 Milliliter (mL) STANDARD_DEVIATION 16.37 |
| Mitral lateral annulus early diastolic peak velocity | 8.899 Centimeter per second (cm/sec) STANDARD_DEVIATION 3.634 | 9.006 Centimeter per second (cm/sec) STANDARD_DEVIATION 3.217 | 9.114 Centimeter per second (cm/sec) STANDARD_DEVIATION 2.991 |
| Mitral peak velocity of early filling (E) | 86.98 Centimeter per second (cm/sec) STANDARD_DEVIATION 40.43 | 75.08 Centimeter per second (cm/sec) STANDARD_DEVIATION 34.13 | 65.56 Centimeter per second (cm/sec) STANDARD_DEVIATION 26.5 |
| Mitral peak velocity of late filling (A) | 54.89 Centimeter per second (cm/sec) STANDARD_DEVIATION 33.64 | 66.51 Centimeter per second (cm/sec) STANDARD_DEVIATION 36.23 | 76.69 Centimeter per second (cm/sec) STANDARD_DEVIATION 37.44 |
| Mitral septal annulus early diastolic peak velocity | 4.949 Centimeter per second (cm/sec) STANDARD_DEVIATION 2.229 | 8.544 Centimeter per second (cm/sec) STANDARD_DEVIATION 11.479 | 12.139 Centimeter per second (cm/sec) STANDARD_DEVIATION 15.744 |
| N-terminal propeptide of BNP (NT-proBNP) | 11972.4 Nanograms per liter (ng/L) STANDARD_DEVIATION 20747.7 | 8015.3 Nanograms per liter (ng/L) STANDARD_DEVIATION 16020.7 | 2927.4 Nanograms per liter (ng/L) STANDARD_DEVIATION 3742.5 |
| Number of participants per NYHA classification NYHA Class II | 6 Participants | 8 Participants | 2 Participants |
| Number of participants per NYHA classification NYHA Class III | 7 Participants | 17 Participants | 10 Participants |
| Pressure gradient of tricuspid valve | 40.937 Millimetre of mercury (mmHg) STANDARD_DEVIATION 19.458 | 46.123 Millimetre of mercury (mmHg) STANDARD_DEVIATION 25.771 | 53.038 Millimetre of mercury (mmHg) STANDARD_DEVIATION 32.335 |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score Clinical Summary Score | 68.0 Scores on a scale | 66.0 Scores on a scale | 41.0 Scores on a scale |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score Overall Summary Score | 67.0 Scores on a scale | 64.5 Scores on a scale | 43.0 Scores on a scale |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score Physical Limitation Score | 71.0 Scores on a scale | 65.0 Scores on a scale | 54.0 Scores on a scale |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score Total Symptom Score | 64.0 Scores on a scale | 61.0 Scores on a scale | 33.0 Scores on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Right atrial mean pressure | 8.8 Millimetre of mercury (mmHg) STANDARD_DEVIATION 5.7 | 7.2 Millimetre of mercury (mmHg) STANDARD_DEVIATION 5.2 | 5.4 Millimetre of mercury (mmHg) STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 7 Participants |
| Tricuspid annular plane systolic excursion | 16.612 Millimeters (mm) STANDARD_DEVIATION 3.734 | 17.383 Millimeters (mm) STANDARD_DEVIATION 4.96 | 18.295 Millimeters (mm) STANDARD_DEVIATION 6.178 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 1 / 13 |
| other Total, other adverse events | 8 / 14 | 9 / 13 |
| serious Total, serious adverse events | 5 / 14 | 3 / 13 |
Outcome results
Primary
Amount of Daily Physical Activity Measured With VitalPatch Biosensor
Amount of daily physical activity was collected and measured with VitalPatch biosensor.
Time frame: Up to Day 84
Population: Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation.
Primary
Daily Physical Activity Level
Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity.
Time frame: At Day 9 and Day 77
Population: Device set (DES): All participants with DynaPort parameters for least one wearing period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Daily Physical Activity Level | Day 9 | 1.612 Meter*second^-2 (m*s^-2) | Standard Deviation 0.135 |
| HFrEF | Daily Physical Activity Level | Day 77 | 1.678 Meter*second^-2 (m*s^-2) | Standard Deviation 0.153 |
| HFpEF | Daily Physical Activity Level | Day 9 | 1.606 Meter*second^-2 (m*s^-2) | Standard Deviation 0.138 |
| HFpEF | Daily Physical Activity Level | Day 77 | 1.586 Meter*second^-2 (m*s^-2) | Standard Deviation 0.144 |
Primary
Daily Steps Count
Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Time frame: At Day 9 and Day 77
Population: Device set (DES): All participants with DynaPort parameters for least one wearing period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Daily Steps Count | Day 9 | 5052 Steps | Standard Deviation 3090 |
| HFrEF | Daily Steps Count | Day 77 | 6627 Steps | Standard Deviation 3851 |
| HFpEF | Daily Steps Count | Day 9 | 3509 Steps | Standard Deviation 1871 |
| HFpEF | Daily Steps Count | Day 77 | 2524 Steps | Standard Deviation 1606 |
Primary
Duration of Daily Physical Activity
Duration of daily physical activity was measured with DynaPort Move Monitor device.
Time frame: At Day 9 and Day 77
Population: Device set (DES): All participants with DynaPort parameters for least one wearing period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Duration of Daily Physical Activity | Active Time - Day 77 | 5.043 Hours | Standard Deviation 1.578 |
| HFrEF | Duration of Daily Physical Activity | Active Time - Day 9 | 4.157 Hours | Standard Deviation 1.631 |
| HFpEF | Duration of Daily Physical Activity | Active Time - Day 9 | 3.843 Hours | Standard Deviation 1.886 |
| HFpEF | Duration of Daily Physical Activity | Active Time - Day 77 | 3.861 Hours | Standard Deviation 2.796 |
Primary
Duration of Daily Physical Activity Measured With VitalPatch Biosensor
Duration of daily physical activity was collected and measured with VitalPatch biosensor.
Time frame: Up to Day 84
Population: Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation.
Primary
Intensity of Daily Physical Activity Measured With VitalPatch Biosensor
Intensity of daily physical activity was collected and measured with VitalPatch biosensor.
Time frame: Up to Day 84
Population: Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation.
Primary
Time Duration Per Activity Status
Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more.
Time frame: At Day 9 and Day 77
Population: Device set (DES): All participants with DynaPort parameters for least one wearing period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Time Duration Per Activity Status | Time in Light Activity State - Day 9 | 1.156 Hours | Standard Deviation 0.632 |
| HFrEF | Time Duration Per Activity Status | Time in Moderate Activity State - Day 77 | 1.471 Hours | Standard Deviation 0.397 |
| HFrEF | Time Duration Per Activity Status | Time in Light Activity State - Day 77 | 1.586 Hours | Standard Deviation 0.723 |
| HFrEF | Time Duration Per Activity Status | Time in Vigorous Activity State - Day 9 | 0.181 Hours | Standard Deviation 0.355 |
| HFrEF | Time Duration Per Activity Status | Time in Sedentary State - Day 77 | 20.415 Hours | Standard Deviation 1.457 |
| HFrEF | Time Duration Per Activity Status | Time in Vigorous Activity State - Day 77 | 0.357 Hours | Standard Deviation 0.562 |
| HFrEF | Time Duration Per Activity Status | Time in Moderate Activity State - Day 9 | 1.365 Hours | Standard Deviation 0.515 |
| HFrEF | Time Duration Per Activity Status | Time in Sedentary State - Day 9 | 20.957 Hours | Standard Deviation 1.18 |
| HFpEF | Time Duration Per Activity Status | Time in Light Activity State - Day 9 | 1.275 Hours | Standard Deviation 0.779 |
| HFpEF | Time Duration Per Activity Status | Time in Sedentary State - Day 9 | 21.196 Hours | Standard Deviation 1.346 |
| HFpEF | Time Duration Per Activity Status | Time in Sedentary State - Day 77 | 21.203 Hours | Standard Deviation 1.402 |
| HFpEF | Time Duration Per Activity Status | Time in Light Activity State - Day 77 | 1.415 Hours | Standard Deviation 1.043 |
| HFpEF | Time Duration Per Activity Status | Time in Moderate Activity State - Day 9 | 1.194 Hours | Standard Deviation 0.459 |
| HFpEF | Time Duration Per Activity Status | Time in Moderate Activity State - Day 77 | 0.995 Hours | Standard Deviation 0.5 |
| HFpEF | Time Duration Per Activity Status | Time in Vigorous Activity State - Day 9 | 0.033 Hours | Standard Deviation 0.036 |
| HFpEF | Time Duration Per Activity Status | Time in Vigorous Activity State - Day 77 | 0.019 Hours | Standard Deviation 0.022 |
Primary
Total Daily Energy Expenditure
Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Time frame: At Day 9 and Day 77
Population: Device set (DES): All participants with DynaPort parameters for least one wearing period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Total Daily Energy Expenditure | Day 9 | 2445 Kilocalorie (kcal) | Standard Deviation 378 |
| HFrEF | Total Daily Energy Expenditure | Day 77 | 2374 Kilocalorie (kcal) | Standard Deviation 322 |
| HFpEF | Total Daily Energy Expenditure | Day 9 | 2380 Kilocalorie (kcal) | Standard Deviation 557 |
| HFpEF | Total Daily Energy Expenditure | Day 77 | 2329 Kilocalorie (kcal) | Standard Deviation 494 |
Secondary
6-minute Walking Distance (6MWD)
6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| HFrEF | 6-minute Walking Distance (6MWD) | 456 Meters |
| HFpEF | 6-minute Walking Distance (6MWD) | 261 Meters |
Secondary
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.
Time frame: At Day 9, Day 77 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Blood Pressure | SBP - Day 77 | 114.1 millimetre of mercury (mmHg) | Standard Deviation 27.7 |
| HFrEF | Blood Pressure | SBP - Day 9 | 108.1 millimetre of mercury (mmHg) | Standard Deviation 14.6 |
| HFrEF | Blood Pressure | DBP - Day 77 | 63.9 millimetre of mercury (mmHg) | Standard Deviation 14.6 |
| HFrEF | Blood Pressure | SBP - Day 84 | 117.6 millimetre of mercury (mmHg) | Standard Deviation 15.2 |
| HFrEF | Blood Pressure | DBP - Day 84 | 70.0 millimetre of mercury (mmHg) | Standard Deviation 12.2 |
| HFrEF | Blood Pressure | DBP - Day 9 | 66.3 millimetre of mercury (mmHg) | Standard Deviation 10.7 |
| HFpEF | Blood Pressure | DBP - Day 84 | 65.1 millimetre of mercury (mmHg) | Standard Deviation 13 |
| HFpEF | Blood Pressure | SBP - Day 9 | 128.8 millimetre of mercury (mmHg) | Standard Deviation 18.6 |
| HFpEF | Blood Pressure | SBP - Day 77 | 126.6 millimetre of mercury (mmHg) | Standard Deviation 14.5 |
| HFpEF | Blood Pressure | SBP - Day 84 | 124.5 millimetre of mercury (mmHg) | Standard Deviation 12.5 |
| HFpEF | Blood Pressure | DBP - Day 9 | 72.7 millimetre of mercury (mmHg) | Standard Deviation 14.6 |
| HFpEF | Blood Pressure | DBP - Day 77 | 64.5 millimetre of mercury (mmHg) | Standard Deviation 12.8 |
Secondary
Copeptin
Blood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Copeptin | Day 84 | 31.743 Picomoles per litre (pmol/L) | Standard Deviation 19.022 |
| HFrEF | Copeptin | Day 9 | 41.553 Picomoles per litre (pmol/L) | Standard Deviation 36.802 |
| HFpEF | Copeptin | Day 84 | 34.221 Picomoles per litre (pmol/L) | Standard Deviation 23.304 |
| HFpEF | Copeptin | Day 9 | 29.457 Picomoles per litre (pmol/L) | Standard Deviation 25.633 |
Secondary
Diameter of the Left Ventricle in Diastole
Diameter of the left ventricle in diastole was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Diameter of the Left Ventricle in Diastole | 64.465 Millimeters (mm) | Standard Deviation 12.425 |
| HFpEF | Diameter of the Left Ventricle in Diastole | 47.705 Millimeters (mm) | Standard Deviation 4.003 |
Secondary
Diameter of the Left Ventricle in Systole
Diameter of the left ventricle in systole was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Diameter of the Left Ventricle in Systole | 53.318 Millimeters (mm) | Standard Deviation 13.067 |
| HFpEF | Diameter of the Left Ventricle in Systole | 35.133 Millimeters (mm) | Standard Deviation 5.369 |
Secondary
Galectin-3
Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Galectin-3 | Day 9 | 16.736 Nanograms per milliliter (ng/mL) | Standard Deviation 10.883 |
| HFrEF | Galectin-3 | Day 84 | 12.637 Nanograms per milliliter (ng/mL) | Standard Deviation 8.082 |
| HFpEF | Galectin-3 | Day 9 | 14.461 Nanograms per milliliter (ng/mL) | Standard Deviation 6.036 |
| HFpEF | Galectin-3 | Day 84 | 17.947 Nanograms per milliliter (ng/mL) | Standard Deviation 14.908 |
Secondary
Growth Differentiation Factor 15 (GDF 15)
Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Growth Differentiation Factor 15 (GDF 15) | Day 9 | 5297.4 Picograms per millilitre (pg/mL) | Standard Deviation 6452.6 |
| HFrEF | Growth Differentiation Factor 15 (GDF 15) | Day 84 | 2796.8 Picograms per millilitre (pg/mL) | Standard Deviation 1942.1 |
| HFpEF | Growth Differentiation Factor 15 (GDF 15) | Day 9 | 1987.7 Picograms per millilitre (pg/mL) | Standard Deviation 913.7 |
| HFpEF | Growth Differentiation Factor 15 (GDF 15) | Day 84 | 2333.3 Picograms per millilitre (pg/mL) | Standard Deviation 1497.8 |
Secondary
Heart Rate
Heart rate data were collected by electrocardiogram (ECG).
Time frame: At Day 9, Day 77 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Heart Rate | Day 9 | 68.0 Beats per minute | Standard Deviation 13.7 |
| HFrEF | Heart Rate | Day 77 | 63.3 Beats per minute | Standard Deviation 15.2 |
| HFrEF | Heart Rate | Day 84 | 68.0 Beats per minute | Standard Deviation 16.4 |
| HFpEF | Heart Rate | Day 9 | 73.6 Beats per minute | Standard Deviation 18 |
| HFpEF | Heart Rate | Day 77 | 70.3 Beats per minute | Standard Deviation 17.2 |
| HFpEF | Heart Rate | Day 84 | 73.3 Beats per minute | Standard Deviation 20.2 |
Secondary
Heart Rate Variability (HRV) Derived From ECG
Heart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensor
Time frame: Up to Day 84
Population: Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation.
Secondary
High Sensitive Troponin T (hsTRT)
Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0)
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | High Sensitive Troponin T (hsTRT) | Day 9 | 46.56 Picograms per millilitre (pg/mL) | Standard Deviation 35 |
| HFrEF | High Sensitive Troponin T (hsTRT) | Day 84 | 33.82 Picograms per millilitre (pg/mL) | Standard Deviation 25.85 |
| HFpEF | High Sensitive Troponin T (hsTRT) | Day 9 | 24.70 Picograms per millilitre (pg/mL) | Standard Deviation 5.98 |
| HFpEF | High Sensitive Troponin T (hsTRT) | Day 84 | 27.00 Picograms per millilitre (pg/mL) | Standard Deviation 8.4 |
Secondary
Human Insulin-like Growth Factor Binding (IGFBP7)
Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Human Insulin-like Growth Factor Binding (IGFBP7) | Day 9 | 293.9 Nanograms per milliliter (ng/mL) | Standard Deviation 156.4 |
| HFrEF | Human Insulin-like Growth Factor Binding (IGFBP7) | Day 84 | 228.8 Nanograms per milliliter (ng/mL) | Standard Deviation 49.5 |
| HFpEF | Human Insulin-like Growth Factor Binding (IGFBP7) | Day 9 | 256.5 Nanograms per milliliter (ng/mL) | Standard Deviation 112.8 |
| HFpEF | Human Insulin-like Growth Factor Binding (IGFBP7) | Day 84 | 242.5 Nanograms per milliliter (ng/mL) | Standard Deviation 98.8 |
Secondary
Human Interleukin-1 Receptor 4 / ST2 (sST2)
Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0)
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | Human Interleukin-1 Receptor 4 / ST2 (sST2) | Day 84 | 26.13 Picograms per litre (pg/L) | Standard Deviation 21.51 |
| HFrEF | Human Interleukin-1 Receptor 4 / ST2 (sST2) | Day 9 | 34.88 Picograms per litre (pg/L) | Standard Deviation 13.63 |
| HFpEF | Human Interleukin-1 Receptor 4 / ST2 (sST2) | Day 84 | 24.35 Picograms per litre (pg/L) | Standard Deviation 9.98 |
| HFpEF | Human Interleukin-1 Receptor 4 / ST2 (sST2) | Day 9 | 23.27 Picograms per litre (pg/L) | Standard Deviation 8.45 |
Secondary
Interventricular Septal Wall Thickness
Interventricular septal wall thickness was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Interventricular Septal Wall Thickness | 13.317 Millimeters (mm) | Standard Deviation 4.667 |
| HFpEF | Interventricular Septal Wall Thickness | 12.578 Millimeters (mm) | Standard Deviation 0.899 |
Secondary
Left Atrial End-systolic Volume
Left atrial end-systolic volume was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Left Atrial End-systolic Volume | 109.200 Milliliter (mL) | Standard Deviation 30.31 |
| HFpEF | Left Atrial End-systolic Volume | 76.833 Milliliter (mL) | Standard Deviation 27.549 |
Secondary
Left Atrial End Systolic Volume Index
Left atrial end systolic volume index was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Left Atrial End Systolic Volume Index | 55.6008 Milliliter per square meter (mL/m^2) | Standard Deviation 17.9289 |
| HFpEF | Left Atrial End Systolic Volume Index | 38.9653 Milliliter per square meter (mL/m^2) | Standard Deviation 18.0952 |
Secondary
Left Ventricular Ejection Fraction
Left ventricular ejection fraction was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Left Ventricular Ejection Fraction | 28.33 Percentage of the volume of blood | Standard Deviation 10.97 |
| HFpEF | Left Ventricular Ejection Fraction | 48.80 Percentage of the volume of blood | Standard Deviation 15.91 |
Secondary
Left Ventricular End-diastolic Volume
Left ventricular end-diastolic volume was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Left Ventricular End-diastolic Volume | 219.667 Milliliter (mL) | Standard Deviation 83.868 |
| HFpEF | Left Ventricular End-diastolic Volume | 97.000 Milliliter (mL) | Standard Deviation 23.13 |
Secondary
Left Ventricular End-systolic Volume
Left ventricular end-systolic volume was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Left Ventricular End-systolic Volume | 154.83 Milliliter (mL) | Standard Deviation 66.02 |
| HFpEF | Left Ventricular End-systolic Volume | 51.60 Milliliter (mL) | Standard Deviation 29.1 |
Secondary
Mitral Lateral Annulus Early Diastolic Peak Velocity
Mitral lateral annulus early diastolic peak velocity was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Mitral Lateral Annulus Early Diastolic Peak Velocity | 8.625 Centimeter per second (cm/sec) | Standard Deviation 2.266 |
| HFpEF | Mitral Lateral Annulus Early Diastolic Peak Velocity | 8.623 Centimeter per second (cm/sec) | Standard Deviation 2.781 |
Secondary
Mitral Peak Velocity of Early Filling (E)
Mitral peak velocity of early filling (E) was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Mitral Peak Velocity of Early Filling (E) | 81.28 Centimeter per second (cm/sec) | Standard Deviation 40.45 |
| HFpEF | Mitral Peak Velocity of Early Filling (E) | 78.53 Centimeter per second (cm/sec) | Standard Deviation 29.66 |
Secondary
Mitral Peak Velocity of Late Filling (A)
Mitral peak velocity of late filling (A) was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Mitral Peak Velocity of Late Filling (A) | 64.43 Centimeter per second (cm/sec) | Standard Deviation 23.98 |
| HFpEF | Mitral Peak Velocity of Late Filling (A) | 67.23 Centimeter per second (cm/sec) | Standard Deviation 29.77 |
Secondary
Mitral Septal Annulus Early Diastolic Peak Velocity
Mitral septal annulus early diastolic peak velocity was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Mitral Septal Annulus Early Diastolic Peak Velocity | 7.418 Centimeter per second (cm/sec) | Standard Deviation 3.296 |
| HFpEF | Mitral Septal Annulus Early Diastolic Peak Velocity | 6.267 Centimeter per second (cm/sec) | Standard Deviation 2.555 |
Secondary
N-terminal Propeptide of BNP (NT-proBNP)
Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFrEF | N-terminal Propeptide of BNP (NT-proBNP) | Day 9 | 10985.4 Nanograms per liter (ng/L) | Standard Deviation 22390.8 |
| HFrEF | N-terminal Propeptide of BNP (NT-proBNP) | Day 84 | 3660.0 Nanograms per liter (ng/L) | Standard Deviation 3463.7 |
| HFpEF | N-terminal Propeptide of BNP (NT-proBNP) | Day 9 | 2051.7 Nanograms per liter (ng/L) | Standard Deviation 2434.9 |
| HFpEF | N-terminal Propeptide of BNP (NT-proBNP) | Day 84 | 2746.6 Nanograms per liter (ng/L) | Standard Deviation 3395.6 |
Secondary
Number of Participants Per NYHA Classification by Visit
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. 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, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS I | 0 Participants |
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS II | 9 Participants |
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS III | 2 Participants |
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS I | 2 Participants |
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS II | 5 Participants |
| HFrEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS III | 3 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS II | 4 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS I | 1 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS I | 1 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS II | 4 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 84 | NYHA CLASS III | 6 Participants |
| HFpEF | Number of Participants Per NYHA Classification by Visit | Day 9 | NYHA CLASS III | 8 Participants |
Secondary
Pressure Gradient of Tricuspid Valve
Pressure gradient of tricuspid valve was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Pressure Gradient of Tricuspid Valve | 35.793 Millimetre of mercury (mmHg) | Standard Deviation 15.524 |
| HFpEF | Pressure Gradient of Tricuspid Valve | 30.982 Millimetre of mercury (mmHg) | Standard Deviation 10.333 |
Secondary
Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients' HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states.
Time frame: At Day 9 and Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Total Symptom Score - Day 9 | 75.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Total Symptom Score - Day 84 | 75.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Clinical Summary Score - Day 9 | 69.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Clinical Summary Score - Day 84 | 67.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Overall Summary Score - Day 9 | 57.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Overall Summary Score - Day 84 | 62.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Physical Limitation Score - Day 9 | 71.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Physical Limitation Score - Day 84 | 73.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Physical Limitation Score - Day 84 | 28.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Total Symptom Score - Day 9 | 48.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Overall Summary Score - Day 9 | 39.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Total Symptom Score - Day 84 | 39.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Physical Limitation Score - Day 9 | 34.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Clinical Summary Score - Day 9 | 40.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Overall Summary Score - Day 84 | 36.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | Clinical Summary Score - Day 84 | 36.0 Scores on a scale |
Secondary
Quality of Life as Measured With the PRO - Activity Scores
REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states.
Time frame: At Day 9 and Day 77
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HFrEF | Quality of Life as Measured With the PRO - Activity Scores | Overall Activity Score - Day 9 | 75.909 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Activity Scores | Overall Activity Score - Day 77 | 108.486 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Activity Scores | General Physical Activity Score - Day 9 | 1.70000 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Activity Scores | General Physical Activity Score - Day 77 | 1.48413 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Activity Scores | General Physical Activity Score - Day 77 | 1.53333 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Activity Scores | Overall Activity Score - Day 9 | 107.708 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Activity Scores | General Physical Activity Score - Day 9 | 1.66667 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Activity Scores | Overall Activity Score - Day 77 | 106.700 Scores on a scale |
Secondary
Quality of Life as Measured With the PRO - Change in Activities and Symptoms
REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question How have your physical activities changed since you were discharged from the hospital: 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions How has your feeling of tiredness changed since you were discharged from the hospital, How has your shortness of breath changed since you were discharged from the hospital and How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital: 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse.
Time frame: At Day 9 and Day 77
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Have Your Physical Activities Changed Since Discharged from Hospital - Day 9 | 2.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Have Your Physical Activities Changed Since Discharged from Hospital - Day 77 | 3.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 9 | 2.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 77 | 2.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 9 | 2.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 77 | 2.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 9 | 4.0 Scores on a scale |
| HFrEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 77 | 2.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 9 | 3.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Have Your Physical Activities Changed Since Discharged from Hospital - Day 9 | 4.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 9 | 4.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Have Your Physical Activities Changed Since Discharged from Hospital - Day 77 | 4.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 77 | 4.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 9 | 4.5 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 77 | 4.0 Scores on a scale |
| HFpEF | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 77 | 4.0 Scores on a scale |
Secondary
Right Atrial Mean Pressure
Right atrial mean pressure was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Right Atrial Mean Pressure | 9.0 Millimetre of mercury (mmHg) | Standard Deviation 6.9 |
| HFpEF | Right Atrial Mean Pressure | 5.8 Millimetre of mercury (mmHg) | Standard Deviation 4.9 |
Secondary
Sit-to-stand Behaviour
Sit-to-stand behaviour was measured with DynaPort Move Monitor device.
Time frame: Up to Day 84
Population: No participant in device set (DES) with evaluable data for this evaluation
Secondary
Sleep Movements
Sleep movements was measured with DynaPort Move Monitor device.
Time frame: Up to Day 84
Population: No participant in device set (DES) with evaluable data for this evaluation
Secondary
Sleep Patterns
Sleep patterns was measured with DynaPort Move Monitor device.
Time frame: Up to Day 84
Population: No participant in device set (DES) with evaluable data for this evaluation
Secondary
Tricuspid Annular Plane Systolic Excursion
Tricuspid annular plane systolic excursion was measured by echocardiography.
Time frame: At Day 84
Population: Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFrEF | Tricuspid Annular Plane Systolic Excursion | 17.833 Millimeters (mm) | Standard Deviation 2.483 |
| HFpEF | Tricuspid Annular Plane Systolic Excursion | 19.000 Millimeters (mm) | Standard Deviation 2.898 |
Other Pre-specified
Number of Participants With Adverse Events
An adverse event (AE) was any untoward medical occurrence in a participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by the investigator.
Time frame: From signing the ICF until follow-up visit (up to 7 months)
Population: Full analysis set (FAS): All participants that were enrolled into the study and that wore at least one device
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HFrEF | Number of Participants With Adverse Events | Any SAE | 5 Participants |
| HFrEF | Number of Participants With Adverse Events | Any AE | 9 Participants |
| HFpEF | Number of Participants With Adverse Events | Any AE | 10 Participants |
| HFpEF | Number of Participants With Adverse Events | Any SAE | 3 Participants |