NCT07257289 Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
| NCT ID | NCT07257289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Hereditary Heart Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2036-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-02-03 with a primary completion date of 2036-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07257289 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 100 Years, studying Hereditary Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07257289 currently recruiting?
Yes, NCT07257289 is actively recruiting participants. Contact the research team at vincent.probst@chu-nantes.fr for enrollment information.
Where is the NCT07257289 trial being conducted?
This trial is being conducted at Bordeaux, France, Brest, France, Clermont-Ferrand, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT07257289 clinical trial?
NCT07257289 is sponsored by Nantes University Hospital. The trial plans to enroll 1,000 participants.