Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

Completed

• Conditions: Cardiomyopathy
• Interventions: Genetic: Identification of genetic polymorphisms

• Registration Number: NCT02852018
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients implanted for primary prevention, an implantable cardioverter defibrillator (ICD) single or double room, for severe cardiomyopathy (EF <35%)
• Patients with ischemic cardiomyopathy or idiopathic dilated cardiomyopathy.- "Appropriate treatment" group: patients who had a rhythmic event (before or after inclusion) appropriately treated either by administering an electric shock or by antiarrhythmic stimulation
• Group "no event" patients who have never received treatment or electrical antiarrhythmic stimulation and with a minimum follow-up of three years before inclusion and did not receive proper treatment during the follow up period of the study

Exclusion Criteria

• Patients implanted with an ICD for primary prevention in the context of a family hereditary disease (long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy, ventricular tachycardia catecholergic right ventricular dysplasia ...).
• Patients with left ventricular function greater than 35%.
• Patients implanted with a defibrillator function resynchronization.
• Patients minors, adults under guardianship and protected persons are eligible under this project.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Appropriate treatment	Identification of genetic polymorphisms	Patients who have a rhythmic event (before or after inclusion) appropriately treated either by administering an electric shock or by antiarrhythmic stimulation
No event	Identification of genetic polymorphisms	Patients who have never received treatment or electrical antiarrhythmic stimulation and with a minimum follow-up of three years before inclusion and did not receive appropriate treatment during the follow up period of the study.

Primary Outcome Measures

Name	Time	Method
Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).	4 years
Identification of polymorphisms frequent (> 5% in the general population) by association study ( "Genome Wide Association Study '(GWAS)) using genotyping technology broadband Axiom (Affymetrix).	4 years

Trial Locations

Locations (18)

CHU Brest; 🇫🇷 Brest, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Clermont-Ferrand.; 🇫🇷 Clermont-Ferrand, France

CH La Rochelle; 🇫🇷 La Rochelle, France

CHU Dijon; 🇫🇷 Dijon, France

CHRU Lille; 🇫🇷 Lille, France

CHU Marseille; 🇫🇷 Marseille, France

CHU Lyon; 🇫🇷 Lyon, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Angers; 🇫🇷 Angers, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CHU Tours; 🇫🇷 Tours, France

CHU Toulouse; 🇫🇷 Toulouse, France