Improving decisions for defibrillator implantation in hypertrophic cardiomyopathy
Official title: Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Run by Assistance Publique - Hôpitaux de Paris · NCT03846297 · Data updated 2026-11-12
This study is trying to create a better way to decide if people with hypertrophic cardiomyopathy should get a defibrillator to prevent sudden cardiac death by using new tests and information.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Boulogne-Billancourt, Hauts-de-Seine) |
| Status | Recruiting |
| Started | September 23, 2020 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | March 16, 2023 |
| Trial ID | NCT03846297 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 16 and older diagnosed with HCM based on specific criteria, whether or not they currently have a defibrillator implanted for primary prevention.
✕Probably not a fit
Patients with specific etiologies like amyloidosis or those who have an ICD implanted for secondary prevention will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the decision-making process for implantable cardioverter defibrillator (ICD) implantation in patients with hypertrophic cardiomyopathy (HCM) by developing a new prediction model for sudden cardiac death (SCD). It will utilize newly identified biomarkers through magnetic resonance imaging (MRI) and genetic analysis in a prospective nationwide study. The study will also conduct a medico-economic analysis to establish optimal guidelines for ICD implantation, considering the benefits, adverse effects, and costs associated with the procedure. Data will be collected from 40 sites, focusing on clinical and biological information during routine patient management.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and effective guidelines for ICD implantation, potentially reducing the risk of sudden cardiac death in patients with HCM.
How similar studies have gone: While there are existing guidelines based on retrospective studies, this approach is novel as it seeks to create a prospective model incorporating new biomarkers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions * Aged ≥ 16 years * Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention) * Affiliation to a social security insurance Exclusion Criteria: * Specific etiologies such as amyloidosis * Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
Where it's running
-
Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,
Boulogne-Billancourt, Hauts-de-Seine, France Recruiting
Study contacts
- Principal investigator: Philippe CHARRON, MD, PhD — Centre de référence maladies cardiaques héréditaires, Hôpital Ambroise Paré & Hôpital Pitié-Salpêtrière
- Study coordinator: Philippe CHARRON, MD, PhD
- Email: philippe.charron@aphp.fr
- Phone: + 33 1 49 09 55 43
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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.