NCT02852018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

7.8 years

First QC Date

July 21, 2016

Last Update Submit

January 19, 2018

Conditions

Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

  • Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).

    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).

    4 years

Study Arms (2)

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

Identification of genetic polymorphismsGENETIC
Appropriate treatmentNo event

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients implanted for primary prevention, an implantable cardioverter defibrillator (ICD) single or double room, for severe cardiomyopathy (EF \<35%)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU Angers

Angers, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

CHU Clermont-Ferrand.

Clermont-Ferrand, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

CH La Rochelle

La Rochelle, France

Location

CHRU Lille

Lille, France

Location

CHU Lyon

Lyon, France

Location

CHU Marseille

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHRU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 2, 2016

Study Start

January 1, 2010

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(18)