Clinical Trials Directory

Trials / Completed

CompletedNCT00799565

Mitral Valve Prolapse (MVP) - France Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,179 (actual)
Sponsor
French Cardiology Society · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
GENETICcatch of blood4 tubes of blood are taken on subjects. Samples are sent in Pr Jeunemaître to extract DNA and stock it. This DNA bank 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

Timeline

Start date
2008-12-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2008-12-01
Last updated
2011-07-14

Locations

26 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00799565. Inclusion in this directory is not an endorsement.