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

NCT ID: NCT02852018

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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Conditions

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Cardiomyopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Appropriate treatment

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

Identification of genetic polymorphisms

Intervention Type GENETIC

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.

Identification of genetic polymorphisms

Intervention Type GENETIC

Interventions

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Identification of genetic polymorphisms

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CHU Brest

Brest, , France

Site Status

CHU Clermont-Ferrand.

Clermont-Ferrand, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CH La Rochelle

La Rochelle, , France

Site Status

CHRU Lille

Lille, , France

Site Status

CHU Lyon

Lyon, , France

Site Status

CHU Marseille

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU Nancy

Nancy, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CHRU Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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PROG/10/77

Identifier Type: -

Identifier Source: org_study_id

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