Mitral Valve Prolapse (MVP) - France Study - Full Text View

Sponsors and Collaborators:	French Cardiology Society Leducq Fundation 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

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:	Screening, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

Resource links provided by NLM:

MedlinePlus related topics: Mitral Valve Prolapse Mobility Aids

U.S. FDA Resources

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:

Genetic polymorphism identification [ Time Frame: at 18 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
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 :

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)
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799565

Contacts

Contact: Albert Alain Hagège, MD, PhD		hagege@club-internet.fr
Contact: Anissa Bouzamondo, MD	33(0)143221379	anissa.bouzamondo@cardio-sfc.org

Locations

France
Hôpital Européen Georges Pompidou	Recruiting
Paris, France, 75015
Contact: Albert Alain Hagège, MD, PhD hagege@club-internet.fr
Sub-Investigator: Laurent Sabbah, MD
Sub-Investigator: Ludivine Perdrix, MD
Sub-Investigator: Agnès Oblak, MD
Sub-Investigator: Jean-Noël Fabiani, MD
Sub-Investigator: Philippe Menasché, MD
Sub-Investigator: Alain Berrebi, MD
Sub-Investigator: Xavier Jeunemaitre, MD
Sub-Investigator: Paul Achouch, MD, PhD
Sub-Investigator: Alain Bel, MD, PhD
Sub-Investigator: Lucien Lecuyer, MD
Clinique Saint Augustin	Recruiting
Bordeaux, France, 33074
Contact: Eric Abergel, MD abergel.eric@gmail.com
Principal Investigator: Eric Abergel, MD
Sub-Investigator: Christophe Chauvel, MD
Sub-Investigator: Patrick Dehant, MD
Hôpital Charles Nicolle	Recruiting
Rouen, France, 76000
Contact: Fabrice Bauer, MD fabrice.bauer@chu-rouen.fr
Principal Investigator: Fabrice Bauer, MD
Hôpital du Bocage	Recruiting
Dijon, France, 21000
Contact: Jean-Christophe Eicher, MD jean-christophe.eicher@chu-dijon.fr
Principal Investigator: Jean-Christophe Eicher, MD
Sub-Investigator: Jean-Eric Wolf, MD
Sub-Investigator: Stéphane Ederhy, MD
Hôpital Henri Mondor	Recruiting
Créteil, France, 94010
Contact: Jean-Luc Monin, MD jean-luc.monin@hmn.aphp.fr
Principal Investigator: Jean-Luc Monin, MD
Sub-Investigator: Thibaud Damy, MD
Principal Investigator: Pascal Guéret, MD, PhD
Sub-Investigator: Philippe Le Corvoisier, MD
Sub-Investigator: Sophie Letulle-Aita, MD
Hôpital Sud	Recruiting
Amiens, France, 80054
Contact: Christophe Tribouilloy, MD tribouilloy.christophe@chu-amiens.fr
Principal Investigator: Christophe Tribouilloy, MD
Hôpital Pontchaillou	Recruiting
Rennes, France, 35033
Contact: Christophe Leclercq, MD christophe.leclercq@chu-rennes.fr
Principal Investigator: Christophe Leclercq, MD
Sub-Investigator: Erwan Donal, MD
Sub-Investigator: Alain Leguerrier, MD
CHU Nancy	Recruiting
Vandoeuvre-les-Nancy, France, 54500
Contact: Yves Juillière, MD, PhD y.juilliere@chu-nancy.fr
Principal Investigator: Yves Juillière, MD, PhD
Sub-Investigator: Juan-Pablo Maureira, MD
Sub-Investigator: Jean-Pierre Villemot, MD
Hôpital Front-Pré	Not yet recruiting
La Seyne sur Mer, France, 83000
Contact: Jean-Michel Tartière, MD jmtartiere@yahoo.fr
Principal Investigator: Jean-Michel Tartière, MD
Hôpital Rangueil	Recruiting
Toulouse, France, 31059
Contact: Pierre Massabuau, MD massabuau.p@chu-toulouse.fr
Sub-Investigator: Michel Galinier, MD, PhD
Principal Investigator: Pierre Massabuau, MD
Hôpital Pitié Salpêtrière	Recruiting
Paris, France, 75013
Contact: Alain Pavie, MD alain.pavie@psl.aphp.fr
Principal Investigator: Alain Pavie, MD
Sub-Investigator: Richard Isnard, MD
Sub-Investigator: Christophe Acar, MD
Sub-Investigator: Stéphane Aubert, MD
Hôpital de la Cavale Blanche	Recruiting
Brest, France, 29609
Contact: Yves Etienne, MD yves.etienne@chu-brest.fr
Principal Investigator: Yannick Jobic, MD
Sub-Investigator: Yves Etienne, MD
Sub-Investigator: Jean-Jacques Blanc, MD,PhD
Hôpital Bichat	Recruiting
Paris, France, 75018
Contact: Guillaume Jondeau, MD, PhD guillaume.jondeau@bch.aphp.fr
Principal Investigator: Guillaume Jondeau, MD, PhD
Sub-Investigator: Eric Brochet, MD
Sub-Investigator: Bernard Iung, MD
Hôpital Cardiologique	Not yet recruiting
Lille, France, 59037
Contact: Anne-Sophie Polge, MD,PhD aspolge@gmail.com
Sub-Investigator: Anne-Sophie Polge, MD, PhD
Principal Investigator: André Vincentelli, MD, PhD
Hôpital Cardiologique du Haut Lévêque	Recruiting
Pessac, France, 33604
Contact: Raymond Pierre Roudaut, MD raymond.roudaut@pu.u-bordeau2.fr
Principal Investigator: Raymond Pierre Roudaut, MD
Sub-Investigator: Stéphane Lafitte, MD
Sub-Investigator: Patricia Réant, MD
Sub-Investigator: Aude Mignot, MD
Hôpital Ambroise Paré	Recruiting
Boulogne, France, 92104
Contact: Olivier Dubourg, MD, PhD olivier.dubourg@apr.aphp.fr
Principal Investigator: Olivier Dubourg, MD, PhD
Sub-Investigator: Nacera Abbou, MD
Sub-Investigator: Nicolas Mansencal, MD
Hôpital Arnaud de Villeneuve	Recruiting
Montpellier, France, 34295
Contact: Catherine Sportouch-Dukhan, MD c-sportouch_dukhan@chu-montpellier.fr
Principal Investigator: Catherine Sportouch-Dukhan, MD
Hôpital de la Timone	Recruiting
Marseille, France, 13385
Contact: Jean-François Avierinos, MD, PhD jfavierinos@ap-hm.fr
Principal Investigator: Jean-françois Avierinos, Md,PhD
Sub-Investigator: Gilbert Habib, MD, PhD
Groupement Hospitalier Est	Recruiting
Lyon, France, 69677
Contact: Jean-François Obadia, Md,PhD jf.o@chu-lyon.fr
Principal Investigator: Jean-François Obadia, MD,PhD
Sub-Investigator: Patrice Bouvagnet, MD
Sub-Investigator: Geneviève Derumeaux, MD,PhD
Hôpital Saint Antoine	Recruiting
PARIS, France, 75571
Contact: Ariel Cohen, MD,PhD ariel.cohen@sat.aphp.fr
Principal Investigator: Ariel Cohen, MD,PhD
Institut Hospitalier Jacques Cartier	Recruiting
Massy, France, 91300
Contact: Bertrand Cormier, MD b-c.cormier@wanadoo.fr
Principal Investigator: Bertrand Cormier, MD
Sub-Investigator: Marie-Christine Mallergue, MD
Hôpital G and R Laennec	Recruiting
Nantes, France, 44093
Contact: Vincent Probst, Md, PhD vincent.probst@chu-nantes.fr
Principal Investigator: Hervé Le Marec, MD,PhD
Principal Investigator: Vincent Probst, Md,PhD
Sub-Investigator: Jean-Noël Trochu, MD,PhD
Hôpital Lariboisière	Recruiting
Paris, France, 75010
Contact: Damien Logeart, MD damien.logeart@lrb.aphp.fr
Principal Investigator: Damien Logeart, MD
Sub-Investigator: Christophe Tournoux, MD
Hôpital Gabriel Montpied	Recruiting
Clermont-Ferrand, France, 63000
Contact: Jean-René Lusson, Md,PhD jrlusson@chu-clermontferrand.fr
Principal Investigator: Jean-René Lusson, MD,PhD
Hôpital Cochin	Recruiting
Paris, France, 75679
Contact: Christophe Meune, MD,PhD christophe.meune@cch.aphp.fr
Principal Investigator: Christophe Meune, Md,PhD
Hôpital Dupuytren	Recruiting
Limoges, France, 87042
Contact: Caroline Etchecopar-Chevreuil, MD carolineetchecopar@yahoo.fr
Principal Investigator: Caroline Etchecopar-Chevreuil, MD
Sub-Investigator: Nicole Darodes, MD
Sub-Investigator: Déborah Postil, MD

Sponsors and Collaborators

French Cardiology Society

Leducq Fundation

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Responsible Party:	French Society of Cardiology ( Pr Pascal Guéret )
Study ID Numbers:	2008-01
Study First Received:	November 24, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00799565 History of Changes
Health Authority:	France: Ministry of Health