Stratifying risk of dangerous heart rhythm problems and heart failure in inherited heart disease
Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
This project will try to use routine clinical data, extra blood or saliva samples, and AI to see if it can predict which people with hereditary heart disease and their relatives are more likely to develop life‑threatening arrhythmias or heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 1 Year to 100 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 15 sites (Bordeaux and 14 other locations) |
| Trial ID | NCT07257289 on ClinicalTrials.gov |
What this trial studies
This is an observational program enrolling index patients with hereditary heart disease and their relatives referred to participating French university hospitals. Investigators will collect clinical data into a secure eCRF and obtain additional biosamples (two EDTA blood tubes, a dry tube for adult biomarker work, or saliva for very young children) taken during routine blood draws. Participants will be followed for up to 10 years with systematic capture of arrhythmias, heart failure events, and sudden cardiac death. An AI‑based data processing pipeline will combine clinical, ECG, and biomarker information to develop individualized risk predictions.
Who should consider this trial
Good fit: Ideal candidates are people with confirmed or suspected hereditary heart disease and their relatives referred to the participating centers who can give written consent (or assent with parental consent for minors) and are covered by the French social security system.
Not a fit: Patients enrolled in concurrent therapeutic trials that could affect outcomes, those under legal guardianship or curatorship, and people without hereditary heart disease are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, the project could help clinicians identify people who truly need an implantable defibrillator and spare low‑risk individuals from unnecessary devices and their complications.
How similar studies have performed: Previous work combining clinical, ECG, genetic and biomarker data has shown promise for risk prediction and AI methods are emerging, but this long‑term, multicenter observational integration remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 14 other locations
- 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, 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)
Study contacts
- Study coordinator: Vincent Probst, PU-PH
- Email: vincent.probst@chu-nantes.fr
- Phone: 02 40 16 56 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.