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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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU Angers, Angers, France
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
Primary outcomes
-
Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).
Time frame: 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
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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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