Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

NCT ID: NCT03846297

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2027-03-31

Brief 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).

Detailed Description

HCM is a genetic disease, usually autosomal dominant, with a prevalence of about 1/500 in the general population. HCM represents a major cause of SCD in the young, and is the first cause of SCD in athletes less than 35 years of age. The only efficient prevention of SCD, apart from exercise restriction, is ICD.

Given this dreadful potential outcome of HCM, the identification of patients that should receive an ICD is of paramount importance. However, the indications for ICD are controversial and very different guidelines are currently available, coming from the American society of Cardiology, the French Haute Autorité de Santé and from the European society of Cardiology. In addition, these guidelines are all based on retrospective studies and have major limitations. The situation faces a critical need of improvement. Thus, this study has been designed with the objective to propose a revision of international recommendations for defibrillator implantation in HCM patients.

This prospective multicenter non-interventional single-arm study is planned to be conducted in 40 sites with a collection of clinical and biological data, carried out as required for the usual management and care of patients. No investigation will be performed specifically for this study except for an additional blood sample collection at baseline during routine outpatient care and annual interview during follow-up.

Conditions

Hypertrophic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe CHARRON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre de référence maladies cardiaques héréditaires, Hôpital Ambroise Paré & Hôpital Pitié-Salpêtrière

Locations

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

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe CHARRON, MD, PhD

Role: CONTACT

philippe.charron@aphp.fr

+ 33 1 49 09 55 43

Facility Contacts

Philippe Charron, MD, PhD

Role: primary

philippe.charron@aphp.fr

+33 1 49 09 55 43

Other Identifiers

AOR17412

Identifier Type: -

Identifier Source: org_study_id