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Identification of Prognostic Parameters in Patients With Senile Amyloid Cardiomyopathy

Identification of Prognostic Parameters in Patients With Senile Amyloid Cardiomyopathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04225754
Acronym
EVAMYLOSE
Enrollment
142
Registered
2020-01-13
Start date
2020-07-21
Completion date
2025-08-31
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Amyloidosis

Brief summary

The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy. The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients. Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM will be evaluated.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Male or female patient, over 75 years old * Social Security Affiliate * Any patient with the diagnosis of cardiac amyloidosis after etiological evaluation in one of the 4 Alpin arc interventional cardiology centers (Grenoble University Hospital, GHM Grenoble, Annecy Hospital and Chambéry Hospital). * Non opposition to participation

Exclusion criteria

* Concomitant ischemic cardiopathy with revascularization following cardiac scintigraphy exploration and subsequent coronary angiography. * Concomitant non-amyloid non-ischemic cardiopathy (valvular cardiopathy) * Major non-cardiac illness (eg, disseminated malignancy, severe neurological dysfunction at the time of diagnosis) or social condition that may preclude participation in a research study * Major patient protected by law (article L1121-8) * Person deprived of liberty (Article L1121-8)

Design outcomes

Primary

MeasureTime frameDescription
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.1 yearRate of occurrence of the primary endpoint: all-cause mortality at 1 year

Secondary

MeasureTime frameDescription
Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis1 yearMinnesota Quality of Life Questionnaire
Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasoundInclusionMeasurements in cardiac echography (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking)
Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.InclusionMeasurement of IHPM in scintigraphy and measurements in cardiac MRI (right and left ventricular function, cardiac mass,% LV fibrosis).
Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.1 yearRate of secondary endpoint: hospitalization for heart failure
Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.inclusionAbnormality on holter frequency (atrial fibrillation and / or bradycardia requiring pacemaker implantation).
Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.InclusionMeasurement of IHPM in myocardial scintigraphy in patients with senile cardiac amyloidosis and a control population paired with age and sex.
Side effect of tafamidis in this population1 yearRate of side effect in function of phenotype of patients (imaging, geriatric evaluation)
Correlations between IHMP and geriatric frailty.Inclusiongrid SEGA-A (short emergency geriatric evaluation)

Countries

France

Contacts

Primary ContactCharlotte Casset, Dr
ccasset@chu-grenoble.fr+33476763627
Backup ContactClémence Charlon
ccharlon@chu-grenoble.fr+33476766652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026