Mitral Valve Prolapse (MVP) - France Study (MVP-France)
Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
Study Overview
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 :
- 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)
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- Hopital Sud
-
Bordeaux, France, 33074
- Clinique Saint Augustin
-
Boulogne, France, 92104
- Hôpital Ambroise Paré
-
Brest, France, 29609
- Hôpital de la Cavale blanche
-
Clermont-Ferrand, France, 63000
- Hôpital Gabriel Montpied
-
Créteil, France, 94010
- Hopital Henri Mondor
-
Dijon, France, 21000
- Hôpital du Bocage
-
La Seyne sur Mer, France, 83000
- Hôpital Front-Pré
-
Lille, France, 59037
- Hôpital Cardiologique
-
Limoges, France, 87042
- Hopital Dupuytren
-
Lyon, France, 69677
- Groupement Hospitalier Est
-
Marseille, France, 13385
- Hôpital de la Timone
-
Massy, France, 91300
- Institut Hospitalier Jacques Cartier
-
Montpellier, France, 34295
- Hopital Arnaud de Villeneuve
-
Nantes, France, 44093
- Hôpital G and R Laennec
-
Paris, France, 75015
- Hôpital Europeén Georges Pompidou
-
Paris, France, 75010
- Hôpital Lariboisière
-
Paris, France, 75679
- Hôpital Cochin
-
Paris, France, 75571
- Hopital Saint Antoine
-
Paris, France, 75013
- Hôpital Pitie Salpétrière
-
Paris, France, 75018
- Hôpital Bichat
-
Pessac, France, 33604
- Hôpital Cardiologique du Haut Lévèque
-
Rennes, France, 35033
- Hôpital Pontchaillou
-
Rouen, France, 76000
- Hôpital Charles Nicolle
-
Toulouse, France, 31059
- Hopital Rangueil
-
Vandoeuvre-les-Nancy, France, 54500
- CHU Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria for MVP patients :
- Male or female subject ≥18 years
- Affiliation to the French social insurance system
- Written informed consent
Idiopathic MVP defined by the presence of criteria 1) and 2) OR of criterion 3) :
- Echographic MVP > 2 mm on the left ventricular parasternal long-axis view
- Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler)
- History of mitral valve surgery for pure mitral regurgitation due to MVP (myxomatous or fibroelastic deficiency) with available detailed operative report.
Exclusion criteria :
- Presence of heart disease causing MVP (rheumatic, HCM…)
- Syndromic disease (Marfan, Ehlers-Danlos…)
Inclusion criteria for healthy subject :
- Male or female subject ≥40 years
- Absence of MVP or absence of mitral valve dystrophy
- Caucasian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
Healthy Volunteers
|
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 |
|
Experimental: 1
Subject with a Mitral Valvular Prolapse
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Genetic polymorphism identification
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Albert Alain Hagège, MD, PhD, Hôpital Européen Georges-Pompidou
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.