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CompletedNCT02852018GENECHOCUpdated Jan 23, 2018

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

An observational study in Cardiomyopathy, sponsored by Nantes University Hospital. Completed at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,500
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Cardiomyopathy

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03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 1,500 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

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Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
1,500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • GeneticIdentification of genetic polymorphisms
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What researchers measure

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

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Study locations

18 sites
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02852018
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Jan 2010
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Jan 23, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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