Mitral Valve Prolapse (MVP) - France Study

Not Applicable

Completed

• Conditions: Mitral Valve Prolapse
• Interventions: Genetic: catch of blood

• Registration Number: NCT00799565
• Lead Sponsor: French Cardiology Society

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 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.

Study Timeline

• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-28
• Study Start: 2008-12
• Study First Posted: 2008-12-01
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1179

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	catch of blood	Subject with a Mitral Valvular Prolapse
2	catch of blood	Healthy Volunteers

Primary Outcome Measures

Name	Time	Method
Genetic polymorphism identification	Day 1

Trial Locations

Locations (26)

Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hôpital de la Cavale Blanche; 🇫🇷 Brest, France

Groupement Hospitalier Est; 🇫🇷 Lyon, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital Front-Pré; 🇫🇷 La Seyne sur Mer, France

Hôpital Sud; 🇫🇷 Amiens, France

Clinique Saint Augustin; 🇫🇷 Bordeaux, France

Hôpital G and R Laennec; 🇫🇷 Nantes, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Hôpital du Bocage; 🇫🇷 Dijon, France

Hôpital Dupuytren; 🇫🇷 Limoges, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Cardiologique; 🇫🇷 Lille, France

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Cardiologique du Haut Lévêque; 🇫🇷 Pessac, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Rangueil; 🇫🇷 Toulouse, France

CHU Nancy; 🇫🇷 Vandoeuvre-les-Nancy, France