Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00799565
Other study ID # 2008-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02499419 - Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP) N/A
Completed NCT02105480 - Automated Algorithm Based Analysis of Phonocardiograms of Newborns
Completed NCT02512341 - Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
Enrolling by invitation NCT04067635 - Primary Mitral Regurgitation Repair
Recruiting NCT06378996 - Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring N/A
Terminated NCT03285724 - Safety and Performance Study of the Harpoon Mitral Valve Repair System N/A
Recruiting NCT03506217 - Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
Completed NCT00665301 - Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000 N/A
Not yet recruiting NCT04299334 - Neochordae Technique in Mitral Valve Repair Phase 1
Completed NCT03470155 - Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Recruiting NCT06341166 - Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
Completed NCT04231903 - Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Not yet recruiting NCT03609931 - Patient Specific Mitral Valve Modeling for Surgical Planning and Training
Recruiting NCT05631730 - Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse Phase 3
Recruiting NCT02552771 - The Canadian Mitral Research Alliance (CAMRA) Trial CardioLink-2 N/A
Recruiting NCT01719211 - Genetic Basis of Mitral Valve Prolapse
Recruiting NCT04190602 - Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Recruiting NCT03113552 - Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
Recruiting NCT06255457 - Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Completed NCT02771275 - Safety and Early Feasibility Study of the Harpoon Medical Device (EFS) N/A