Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy

Cardiac Amyloidosis Clinical Trial

— EVAMYLOSE  

Official title:

Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225754
• Other study ID #: 38RC19.386
• Secondary ID: 2019-A03024-53
• Status: Recruiting
• Start date: July 21, 2020
• Est. completion date: August 2025

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: Charlotte Casset, Dr
• Phone: +33476763627
• Email: ccasset[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Cardiomyopathies

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis	Minnesota Quality of Life Questionnaire	1 year
Secondary	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
Secondary	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
Secondary	Correlations between IHMP and geriatric frailty.	grid SEGA-A (short emergency geriatric evaluation)	Inclusion
Secondary	Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.	Abnormality on holter frequency (atrial fibrillation and / or bradycardia requiring pacemaker implantation).	inclusion
Secondary	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
Secondary	Side effect of tafamidis in this population	Rate of side effect in function of phenotype of patients (imaging, geriatric evaluation)	1 year