Mitral Valve Prolapse (MVP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

NCT03884426

Mitral Valve Prolapse Genetic Disease

UNKNOWN

Genetic Basis of Mitral Valve Prolapse

NCT01719211

Mitral Valve Prolapse

RECRUITING

Genetics of Ventriculo-arterial Discordance

NCT05330338

Heart Defects, Congenital

ACTIVE_NOT_RECRUITING NA

Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

NCT00647088

Aortic Valve Stenosis

UNKNOWN

PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure

NCT01113268

ST Elevation (STEMI) Myocardial Infarction of Other Sites

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Subject with a Mitral Valvular Prolapse

Group Type EXPERIMENTAL

catch of blood

Intervention Type GENETIC

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

Group Type EXPERIMENTAL

catch of blood

Intervention Type GENETIC

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

* Male or female subject ≥40 years
* Absence of MVP or absence of mitral valve dystrophy
* Caucasian