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
| Type | Name | Description |
|---|---|---|
| GENETIC | catch of blood | 4 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.