Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)

Not yet recruiting

• Conditions: Arrhythmogenic Cardiomyopathy
• Interventions: Biological: Prospective; Other: Retrospective

• Registration Number: NCT05569356
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.

Detailed Description

The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.

Many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.

The objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13
• Study Start: 2022-10-20
• Primary Completion: 2032-10-20
• Study Completion: 2032-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Adult patient (age ≥ 18 years old)
2. Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force
3. Patient carrying a pathogenic mutation responsible for cardiomyopathy
4. Patient informed individually of the research

Exclusion Criteria

1. Patients under curatorship/guardianship
2. Pregnant women
3. Patients who expressed their opposition to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)	Prospective	-
Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)	Retrospective	-

Primary Outcome Measures

Name	Time	Method
Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC)	10 years

Secondary Outcome Measures

Name	Time	Method
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time	10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data	10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.	10 years
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging	10 years
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)	10 years
Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR	10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain	10 years

Trial Locations

Locations (1)

Institut de Cardiologie de la Pitié-Salpêtrière; 🇫🇷 Paris, France