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

Cardiomyopathy Clinical Trial

— GENECHOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852018
• Other study ID #: PROG/10/77
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: January 19, 2018
• Start date: January 2010
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Intervention

Genetic:
• Identification of genetic polymorphisms

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	CHU Clermont-Ferrand.	Clermont-Ferrand
France	CHU Dijon	Dijon
France	CHU Grenoble	Grenoble
France	CH La Rochelle	La Rochelle
France	CHRU Lille	Lille
France	CHU Lyon	Lyon
France	CHU Marseille	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	CHU Rennes	Rennes
France	CHU Rouen	Rouen
France	CHRU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).		4 years
Primary	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