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

This study has been completed.
Sponsor:
Collaborators:
Leducq Foundation
Institut National de la Santé Et de la Recherche Médicale, France
Centre National Français de Genotypage
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00799565
First received: November 24, 2008
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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 Intervention
Mitral Valve Prolapse
Genetic: catch of blood

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Genetic polymorphism identification [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 1179
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Cochin
Paris, France, 75679
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Pitié Salpêtrière
Paris, France, 75013
Hôpital Saint Antoine
Paris, France, 75571
Hôpital Lariboisière
Paris, France, 75010
Hôpital Bichat
Paris, France, 75018
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 Français de Genotypage
Investigators
Principal Investigator: Albert Alain Hagège, MD, PhD Hôpital Européen Georges Pompidou
  More Information

Additional Information:
No publications provided

Responsible Party: Pr Geneviève Derumeaux, French Society of Cardiology
ClinicalTrials.gov Identifier: NCT00799565     History of Changes
Other Study ID Numbers: 2008-01
Study First Received: November 24, 2008
Last Updated: July 13, 2011
Health Authority: France: Ministry of Health

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:
Mitral Valve Prolapse
Neurocirculatory Asthenia
Orthostatic Intolerance
Prolapse
Anxiety Disorders
Autonomic Nervous System Diseases
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Heart Valve Prolapse
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathological Conditions, Anatomical
Primary Dysautonomias
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014