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

January 19, 2018 updated by: Nantes University Hospital
The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Bordeaux, France
        • CHU Bordeaux
      • Brest, France
        • CHU Brest
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand.
      • Dijon, France
        • CHU Dijon
      • Grenoble, France
        • CHU Grenoble
      • La Rochelle, France
        • CH La Rochelle
      • Lille, France
        • CHRU Lille
      • Lyon, France
        • CHU Lyon
      • Marseille, France
        • CHU Marseille
      • Montpellier, France
        • Chu Montpellier
      • Nancy, France
        • CHU Nancy
      • Nantes, France
        • CHU Nantes
      • Rennes, France
        • Chu Rennes
      • Rouen, France
        • CHU Rouen
      • Strasbourg, France
        • CHRU Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Genetic analysis will compare 500 patients implanted with an ICD for primary prevention and having received an appropriate shock and another 500 patients implanted with an ICD for primary prevention and have not received appropriate shock after a minimum follow-up three years before inclusion. To allow the matching of two groups, it requires to recruit 500 patients in the "appropriate treatment" group and 1000 patients in the "no event" group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).
Time Frame: 4 years
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROG/10/77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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