NCT07257289

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
3 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Dec 2036

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2036

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2036

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

November 20, 2025

Last Update Submit

March 25, 2026

Conditions

Hereditary Heart Diseases

Outcome Measures

Primary Outcomes (1)

  • Arrhythmic and heart failure risk stratification

    to assess the arrhythmic risk and/or risk of heart failure in patients with hereditary heart disease at 5, 8 and 10 years, using a model combining clinical, electrocardiographic, imaging, genetic and biomarker data.

    5, 8 and 10 years

Secondary Outcomes (2)

  • Demographics data

    5, 8 and 10 years

  • Diagnosis of Brugada syndrome

    5 years

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult and minor patients with hereditary heart disease or cardiomyopathies and their relatives.

You may qualify if:

  • 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

You may not qualify if:

  • I. Patients participating in a therapeutic trial that may interfere with the research results II. Patients under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU de Brest

Brest, France

NOT YET RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CHU de La Rochelle

La Rochelle, France

NOT YET RECRUITING

CHU de Limoges

Limoges, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Poitiers

Poitiers, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

CHU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

CHU de Tours

Tours, France

NOT YET RECRUITING

CHU de la Martinique

Fort-de-France, Martinique

NOT YET RECRUITING

CHU de la Réunion

Saint-Pierre, Reunion

NOT YET RECRUITING

Central Study Contacts

Vincent Probst, PU-PH

CONTACT

02 40 16 56 99vincent.probst@chu-nantes.fr

Aurélie Thollet

CONTACT

aurelie.thollet@chu-nantes.fr

Study Design

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

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

February 3, 2036

Study Completion (Estimated)

December 12, 2036

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

MA(1)RE(1)FR(13)