Clinical trial NCT04225754: Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy
Official title: Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.
timeFrame: 1 year
Secondary outcomes:
measure: Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.
timeFrame: 1 year
measure: Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis
timeFrame: 1 year
measure: Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound
timeFrame: Inclusion
measure: Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.
timeFrame: Inclusion
measure: Correlations between IHMP and geriatric frailty.
timeFrame: Inclusion
measure: Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.
timeFrame: inclusion
measure: Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.
timeFrame: Inclusion
measure: Side effect of tafamidis in this population
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Charlotte CASSET
role: PRINCIPAL_INVESTIGATOR
References: