Mitral Valve Prolapse (MVP) - France Study

Mitral Valve Prolapse Clinical Trial

— MVP-France  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799565
• Other study ID #: 2008-01
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: July 13, 2011
• Start date: December 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1179
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Sud	Amiens
France	Clinique Saint Augustin	Bordeaux
France	Hôpital Ambroise Paré	Boulogne
France	Hôpital de la Cavale Blanche	Brest
France	Hôpital Gabriel Montpied	Clermont-Ferrand
France	Hôpital Henri Mondor	Créteil
France	Hôpital du Bocage	Dijon
France	Hôpital Front-Pré	La Seyne sur Mer
France	Hôpital Cardiologique	Lille
France	Hôpital Dupuytren	Limoges
France	Groupement Hospitalier Est	Lyon
France	Hôpital de la Timone	Marseille
France	Institut Hospitalier Jacques Cartier	Massy
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Hôpital G and R Laennec	Nantes
France	Hôpital Bichat	Paris
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Cardiologique du Haut Lévêque	Pessac
France	Hôpital Pontchaillou	Rennes
France	Hôpital Charles Nicolle	Rouen
France	Hôpital Rangueil	Toulouse
France	CHU Nancy	Vandoeuvre-les-Nancy

Sponsors (4)

Lead Sponsor	Collaborator
French Cardiology Society	Centre National de Génotypage, Institut National de la Santé Et de la Recherche Médicale, France, Leducq Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic polymorphism identification		Day 1	No