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

NCT ID: NCT04225754

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte CASSET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charlotte Casset, Dr

Role: CONTACT

+33476763627

Clémence Charlon

Role: CONTACT

+33476766652

Facility Contacts

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Clémence Charlon

Role: primary

+33476766652

Other Identifiers

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2019-A03024-53

Identifier Type: OTHER

Identifier Source: secondary_id

38RC19.386

Identifier Type: -

Identifier Source: org_study_id

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