Informations générales (source: ClinicalTrials.gov)
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy (OPTIM-HCM)
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2020
mars 2027
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Ambroise Paré | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Bicêtre | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Bichat | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Cochin | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | CHARRON Philippe | 18/04/2025 07:56:09 | Contacter | ||
Critères
Tous
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
- 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
- Specific etiologies such as amyloidosis
- Patients with ICD as secondary prevention (after aborted SCD or sustained
ventricular arrhythmia)