Stratifying risk of dangerous heart rhythm problems and heart failure in inherited heart disease
Official title: Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
Run by Nantes University Hospital · NCT07257289 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 15 sites (Bordeaux and 14 other locations) |
| Status | Recruiting |
| Started | February 3, 2026 |
| Main results expected | February 3, 2036 |
| Study ends | December 12, 2036 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07257289 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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CHU de Nantes
Nantes, France Recruiting -
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
Show 9 more locations
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CHU de Limoges
Limoges, France Not yet recruiting -
CHU de Montpellier
Montpellier, France Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.