Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy (EVAMYLOSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Amyloidosis

• Study Type: Observational
• Enrollment (Anticipated): 142

Contacts and Locations

• Study Contact: Name: Clémence Charlon; Phone Number: +33476766652; Email: ccharlon@chu-grenoble.fr
• Study Contact Backup: Name: Charlotte Casset, Dr; Phone Number: +33476763627; Email: ccasset@chu-grenoble.fr

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • Recruiting
    • CHU Grenoble Alpes
    • Contact: Clémence Charlon; Phone Number: +33476766652
    • Principal Investigator: Charlotte CASSET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient whose standardized etiological investigations have made the diagnosis of a senile amyloid cardiomyopathy in one of the 4 centers of interventional cardiology of the Alpine arc (CHU Grenoble, GHM Grenoble, CH Annecy, and CH Chambery)

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.	Rate of occurrence of the primary endpoint: all-cause mortality at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.	Rate of secondary endpoint: hospitalization for heart failure	1 year
Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis	Minnesota Quality of Life Questionnaire	1 year
Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound	Measurements in cardiac echography (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking)	Inclusion
Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.	Measurement of IHPM in scintigraphy and measurements in cardiac MRI (right and left ventricular function, cardiac mass,% LV fibrosis).	Inclusion
Correlations between IHMP and geriatric frailty.	grid SEGA-A (short emergency geriatric evaluation)	Inclusion
Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.	Abnormality on holter frequency (atrial fibrillation and / or bradycardia requiring pacemaker implantation).	inclusion
Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.	Measurement of IHPM in myocardial scintigraphy in patients with senile cardiac amyloidosis and a control population paired with age and sex.	Inclusion
Side effect of tafamidis in this population	Rate of side effect in function of phenotype of patients (imaging, geriatric evaluation)	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Charlotte CASSET, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis; Cardiomyopathies
• Other Study ID Numbers: 38RC19.386; 2019-A03024-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No