Mitral Valve Prolapse (MVP) - France Study (MVP-France)
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Purpose
| 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 |
- 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 :
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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) :
- Echographic MVP > 2 mm on the left ventricular parasternal long-axis view
- Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler)
- 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00799565
| 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 Lariboisière | |
| Paris, France, 75010 | |
| Hôpital Pitié Salpêtrière | |
| Paris, France, 75013 | |
| Hôpital Européen Georges Pompidou | |
| Paris, France, 75015 | |
| Hôpital Bichat | |
| Paris, France, 75018 | |
| Hôpital Saint Antoine | |
| Paris, France, 75571 | |
| Hôpital Cochin | |
| Paris, France, 75679 | |
| 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 | |
| Principal Investigator: | Albert Alain Hagège, MD, PhD | Hôpital Européen Georges Pompidou |
More Information
| 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:
|
Prolapse Mitral Valve Prolapse Pathological Conditions, Anatomical Heart Valve Prolapse |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 27, 2016