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

NCT04225754 | Unknown

• 2 other identifiers: 38RC19.3862019-A03024-53
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.

  1 year

• Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis

  1 year

• Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound

  Inclusion

• Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.

  Inclusion

• Correlations between IHMP and geriatric frailty.

  Inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Charlotte CASSET

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Casset, Dr

CONTACT

+33476763627; ccasset@chu-grenoble.fr

Clémence Charlon

CONTACT

+33476766652; ccharlon@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 13, 2020
• Study Start: July 21, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

FR (1)