Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
Recruiting · NCT07257289 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nantes University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Inclusion criteria
- I. hereditary heart disease II. All relatives of patients III. Patients referred to the reference centre for suspected hereditary rhythm disorders or cardiomyopathies IV. Written consent V. social security scheme
Exclusion criteria
- I. Patients participating in a therapeutic trial that may interfere with the research results II. Patients under guardianship or curatorship.
Where it is running
15 locations listed.
- 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 Martinique - Fort-de-France, Martinique
- 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 la Réunion - Saint-Pierre, Reunion
- CHU de Strasbourg - Strasbourg, France
- CHU de Toulouse - Toulouse, France
- CHU de Tours - Tours, France