Predicting sudden cardiac death risk in hypertrophic cardiomyopathy
Studies a new way to predict sudden death in people with thickened heart muscle.
Plain-language title generated from the registry record
Registry title: Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Key facts
- Where
- Boulogne-Billancourt, FranceSee the site
Where in France
- Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,Boulogne-Billancourt, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT03846297
- Record updated
- 16 March 2023
- Original description
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.Read full original descriptionShow less
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
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).
Inclusion: 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: Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia); Specific etiologies such as amyloidosis.