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

Nantes University Hospital18 sites in 1 country1,500 target enrollmentJanuary 2010

ConditionsCardiomyopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiomyopathy
Sponsor: Nantes University Hospital
Enrollment: 1500
Locations: 18
Primary Endpoint: Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

November 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).

Time Frame: 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).

Time Frame: 4 years