Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopa
The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imag
| Condition(s) | Hypertrophic Cardiomyopathy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk. The secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved). |
| Who can participate | 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) |
| Ages | 16 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Boulogne-Billancourt, Hauts-de-Seine, France |
| Start date | 2020-09-23 |
| NCT ID | NCT03846297 |
| Official listing | https://clinicaltrials.gov/study/NCT03846297 |