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RECRUITING
NCT07257289

Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

Sudden cardiac death (SCD) is one of the leading causes of death in developed countries. These deaths (more than 5,000 per year in France) are due to hereditary arrhythmias or cardiomyopathies. Early diagnosis of SCD is often achieved through family screening, but the main challenge is to stratify the risk of SCD in these patients. Indeed, prevention of SCD relies mainly on the implantation of an automatic defibrillator. The challenge is to identify patients who will develop SCD and avoid implanting an implantable cardioverter defibrillator (ICD) in patients who will never develop arrhythmias but who will face complications related to the ICD (inappropriate shocks, infection, lead failure), leading to a reduced quality of life and significant costs for the healthcare system. However, there is a lack of relevant clinical and biological markers for risk stratification, which rules out any possibility of preventive screening. Most of the clinical and ECG (electrocardiogram) parameters identifying an increased risk of SCD have not been reproduced in replication studies. In this project, the investigator will develop a data processing and analysis pipeline using artificial intelligence methods to assess the individual risk of serious arrhythmic events or heart failure in patients with hereditary arrhythmic diseases or cardiomyopathies through the automated processing of multimodal data (clinical data, electrocardiogram (ECG), imaging (echocardiography, MRI magnetic resonance imaging), genetic data, biomarkers).

Key Details

Gender

All

Age Range

1 Year - 100 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-02-03

Completion Date

2036-12-12

Last Updated

2026-03-27

Healthy Volunteers

No

Locations (15)

CHU de Bordeaux

Bordeaux, France

CHU de Brest

Brest, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU de Dijon

Dijon, France

CHU de La Rochelle

La Rochelle, France

CHU de Limoges

Limoges, France

CHU de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

CHU de Poitiers

Poitiers, France

CHU de Rennes

Rennes, France

CHU de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

CHU de Tours

Tours, France

CHU de la Martinique

Fort-de-France, Martinique

CHU de la Réunion

Saint-Pierre, Reunion