NCT00799565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

2.6 years

First QC Date

November 24, 2008

Last Update Submit

July 13, 2011

Conditions

Mitral Valve Prolapse

Keywords

Mitral Valve prolapseechographygenetic studystudy case-witnessPatients with a Mitral Valve Prolapse

Outcome Measures

Primary Outcomes (1)

  • Genetic polymorphism identification

    Day 1

Study Arms (2)

1

EXPERIMENTAL

Subject with a Mitral Valvular Prolapse

Genetic: catch of blood

2

EXPERIMENTAL

Healthy Volunteers

Genetic: catch of blood

Interventions

catch of bloodGENETIC

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of heart disease causing MVP (rheumatic, HCM…)
  • Syndromic disease (Marfan, Ehlers-Danlos…)
  • Male or female subject ≥40 years
  • Absence of MVP or absence of mitral valve dystrophy
  • Caucasian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Hôpital Sud

Amiens, 80054, France

Location

Clinique Saint Augustin

Bordeaux, 33074, France

Location

Hôpital Ambroise Paré

Boulogne, 92104, France

Location

Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital du Bocage

Dijon, 21000, France

Location

Hôpital Front-Pré

La Seyne-sur-Mer, 83000, France

Location

Hôpital Cardiologique

Lille, 59037, France

Location

Hôpital Dupuytren

Limoges, 87042, France

Location

Groupement Hospitalier Est

Lyon, 69677, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital G and R Laennec

Nantes, 44093, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Hôpital Saint Antoine

Paris, 75571, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Hôpital Cardiologique du Haut Lévêque

Pessac, 33604, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Charles Nicolle

Rouen, 76000, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Albert Alain Hagège, MD, PhD

    Hôpital Européen Georges-Pompidou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2008

First Posted

December 1, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 14, 2011

Record last verified: 2011-07

Locations

FR(26)