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

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ClinicalTrials.gov Identifier: NCT02852018
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiomyopathy Genetic: Identification of genetic polymorphisms

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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 : January 2010
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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



Primary Outcome Measures :
  1. Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting). [ Time Frame: 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). [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852018


Locations
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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, France
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02852018     History of Changes
Other Study ID Numbers: PROG/10/77
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases