Mitral Valve Prolapse (MVP) - France Study (MVP-France)

July 13, 2011 updated by: French Cardiology Society

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • Hopital Sud
      • Bordeaux, France, 33074
        • Clinique Saint Augustin
      • Boulogne, France, 92104
        • Hopital Ambroise Pare
      • Brest, France, 29609
        • Hôpital de la cavale Blanche
      • Clermont-Ferrand, France, 63000
        • Hôpital Gabriel Montpied
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon, France, 21000
        • Hopital Du Bocage
      • La Seyne sur Mer, France, 83000
        • Hôpital Front-Pré
      • Lille, France, 59037
        • Hopital 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
        • Hôpital Arnaud De Villeneuve
      • Nantes, France, 44093
        • Hôpital G and R Laennec
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75679
        • Hopital Cochin
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Paris, France, 75013
        • Hopital Pitie Salpetriere
      • Paris, France, 75018
        • Hopital Bichat
      • Pessac, France, 33604
        • Hôpital Cardiologique du Haut Lévêque
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Rouen, France, 76000
        • Hopital Charles Nicolle
      • Toulouse, France, 31059
        • Hopital Rangueil
      • Vandoeuvre-les-Nancy, France, 54500
        • Chu Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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) :

    1. Echographic MVP > 2 mm on the left ventricular parasternal long-axis view
    2. Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler)
    3. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Albert Alain Hagège, MD, PhD, Hopital Europeen Georges-Pompidou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

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.

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