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

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ClinicalTrials.gov Identifier: NCT00799565
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : July 14, 2011
Sponsor:
Collaborators:
Leducq Foundation
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de Génotypage
Information provided by:
French Cardiology Society

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Valve Prolapse Genetic: catch of blood Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1179 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
Study Start Date : December 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Subject with a Mitral Valvular Prolapse
 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
Experimental: 2
Healthy Volunteers
 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


Outcome Measures
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Primary Outcome Measures :
  1. Genetic polymorphism identification [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799565


Locations
France
Hôpital Sud
Amiens, France, 80054
Clinique Saint Augustin
Bordeaux, France, 33074
Hôpital Ambroise Paré
Boulogne, France, 92104
Hôpital de la Cavale Blanche
Brest, France, 29609
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63000
Hôpital Henri Mondor
Créteil, France, 94010
Hôpital du Bocage
Dijon, France, 21000
Hôpital Front-Pré
La Seyne sur Mer, France, 83000
Hôpital Cardiologique
Lille, France, 59037
Hôpital Dupuytren
Limoges, France, 87042
Groupement Hospitalier Est
Lyon, France, 69677
Hôpital de la Timone
Marseille, France, 13385
Institut Hospitalier Jacques Cartier
Massy, France, 91300
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Hôpital G and R Laennec
Nantes, France, 44093
Hôpital Lariboisière
Paris, France, 75010
Hôpital Pitié Salpêtrière
Paris, France, 75013
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Bichat
Paris, France, 75018
Hôpital Saint Antoine
Paris, France, 75571
Hôpital Cochin
Paris, France, 75679
Hôpital Cardiologique du Haut Lévêque
Pessac, France, 33604
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76000
Hôpital Rangueil
Toulouse, France, 31059
CHU Nancy
Vandoeuvre-les-Nancy, France, 54500
Sponsors and Collaborators
French Cardiology Society
Leducq Foundation
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de Génotypage
Investigators
Principal Investigator: Albert Alain Hagège, MD, PhD Hôpital Européen Georges-Pompidou
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Pr Geneviève Derumeaux, French Society of Cardiology
ClinicalTrials.gov Identifier: NCT00799565     History of Changes
Other Study ID Numbers: 2008-01
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by French Cardiology Society:
Mitral Valve prolapse
echography
genetic study
study case-witness
Patients with a Mitral Valve Prolapse

Additional relevant MeSH terms:
Prolapse
Mitral Valve Prolapse
Pathological Conditions, Anatomical
Heart Valve Prolapse
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases