Improving decisions for defibrillator implantation in hypertrophic cardiomyopathy
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Boulogne-Billancourt, Hauts-de-Seine) |
| Trial ID | NCT03846297 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there are existing guidelines based on retrospective studies, this approach is novel as it seeks to create a prospective model incorporating new biomarkers.
Eligibility criteria
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 this trial is running
Boulogne-Billancourt, Hauts-de-Seine
- 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
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.