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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

November 24, 2008
July 13, 2011
December 2008
July 2011   (final data collection date for primary outcome measure)
Genetic polymorphism identification [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Genetic polymorphism identification [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00799565 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mitral Valve Prolapse (MVP) - France Study
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Mitral Valve 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: 1
    Subject with a Mitral Valvular Prolapse
    Intervention: Genetic: catch of blood
  • Experimental: 2
    Healthy Volunteers
    Intervention: Genetic: catch of blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1179
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00799565
2008-01
Yes
Pr Geneviève Derumeaux, French Society of Cardiology
French Cardiology Society
  • Leducq Foundation
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Centre National Français de Genotypage
Principal Investigator: Albert Alain Hagège, MD, PhD Hôpital Européen Georges Pompidou
French Cardiology Society
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP