Clinical Trial: Mitral Valve Prolapse (MVP) - France Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

Brief Summary: This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.

Detailed Summary:

Two MVP populations will be defined in that study, either with the classical Barlow (myxomatous) disease or the fibroelastic degenerescence (thin and redundant leaflets).

MVP adult patients (> 18 year-old) will be included if they present the following 1) or 2) criteria :

  1. 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view > 2 mm AND leaflet thickness > 4 mm or mitral regurgitation > 2 + (using color Doppler)
  2. Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence (with operative report available)

Patients will be excluded in case of associated heart disease (hypertrophic cardiomyopathy, rheumatismal disease…) or syndromic disease (Marfan, Ehlers-Danlos…).

Around 30 (cardiology, cardiovascular surgery) french centers will participate to this study. An e-CRF will be used to collect clinical data. A genetic core lab will collect the DNA samples. An echocardiographic core lab will collect and read all the echo recordings.

DNA analysis will be compared between the patient group and spouses of the patients used as controls. In case of inadequacies concerning group size or age, available genotyped cohorts will be used.


Sponsor: French Cardiology Society

Current Primary Outcome: Genetic polymorphism identification [ Time Frame: Day 1 ]

Original Primary Outcome: Genetic polymorphism identification

Current Secondary Outcome:

Original Secondary Outcome:

Information By: French Cardiology Society

Dates:
Date Received: November 24, 2008
Date Started: December 2008
Date Completion:
Last Updated: July 13, 2011
Last Verified: July 2011