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OpenTrials
Completed

NCT Number: NCT02852018

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

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

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Identification of genetic polymorphisms

Genetic

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: GENECHOC

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2016
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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