Clinical trial NCT00799565: Mitral Valve Prolapse (MVP) - France Study
Official title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Prolapse
Keywords: Mitral Valve prolapse
echography
genetic study
study case-witness
Patients with a Mitral Valve Prolapse
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Leducq Foundation
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de Génotypage
First posted: 2008-12-01
Enrollment: 1179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Genetic polymorphism identification
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Sud
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Boulogne
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Hôpital du Bocage
city: La Seyne sur Mer
country: France
facility: Hôpital Front-Pré
city: Lille
country: France
facility: Hôpital Cardiologique
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Lyon
country: France
facility: Groupement Hospitalier Est
city: Marseille
country: France
facility: Hôpital de la Timone
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Hôpital G and R Laennec
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Vandoeuvre-les-Nancy
country: France
facility: CHU Nancy
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Albert Alain Hagège, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: