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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02852018
Collaborator
(none)
1,500
18
94
83.3
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Identification of genetic polymorphisms

Study Design

Study Type:
Observational
Actual Enrollment :
1500 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Appropriate treatment

Patients who have a rhythmic event (before or after inclusion) appropriately treated either by administering an electric shock or by antiarrhythmic stimulation

Genetic: Identification of genetic polymorphisms

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 appropriate treatment during the follow up period of the study.

Genetic: Identification of genetic polymorphisms

Outcome Measures

Primary Outcome Measures

  1. Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting). [4 years]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France
2 CHU Bordeaux Bordeaux France
3 CHU Brest Brest France
4 CHU Clermont-Ferrand. Clermont-Ferrand France
5 CHU Dijon Dijon France
6 CHU Grenoble Grenoble France
7 CH La Rochelle La Rochelle France
8 CHRU Lille Lille France
9 CHU Lyon Lyon France
10 CHU Marseille Marseille France
11 CHU Montpellier Montpellier France
12 CHU Nancy Nancy France
13 CHU Nantes Nantes France
14 CHU Rennes Rennes France
15 CHU Rouen Rouen France
16 CHRU Strasbourg Strasbourg France
17 CHU Toulouse Toulouse France
18 CHU Tours Tours France

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02852018
Other Study ID Numbers:
  • PROG/10/77
First Posted:
Aug 2, 2016
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2018