Genetic and Phenotypic Characteristics of Mitral Valve Prolapse (MVP)

August 27, 2021 updated by: Nantes University Hospital
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Study Overview

Status

Recruiting

Conditions

Detailed Description

After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France, 29200
        • Not yet recruiting
        • Brest University Hospital
        • Contact:
        • Sub-Investigator:
          • Yves Etienne, PH
        • Sub-Investigator:
          • Yannick Jobic, PH
      • Nantes, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Thierry Le Tourneau, PU-PH
      • Rennes, France, 35033
        • Recruiting
        • Rennes University Hospital
        • Contact:
        • Principal Investigator:
          • Erwan Donal, PU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of both sex of any age with typical mitral valve prolapse and relatives examined during familial screening

Description

Inclusion Criteria:

  • Patients of any age
  • with typical mitral valve prolapse
  • relatives examined during familial screening

Exclusion Criteria:

  • Refusal of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with MVP
The patients concerned are patients with known or recently discovered Barlow-type mitral prolapse, whatever the degree of severity.
Normal relatives
Related healthy patients, for an average of 6 individuals per family

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MVP defined by a superior displacement of at least 2 mm
Time Frame: At Day 0
MVP defined by a superior displacement of at least 2 mm
At Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)
Time Frame: At Day 0
Leaflets length ; Chordae length ; Annulus diameter
At Day 0
Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)
Time Frame: At Day 0
Papillary muscles aspect ; Right Ventricle function ; Left Ventricle Ejection Fraction
At Day 0
Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)
Time Frame: At Day 0
Left ventricle and atrium sizes ; right ventricle size ; right Atrium size
At Day 0
Comprehensive mitral valve apparatus characterization per size of items
Time Frame: At Day 0
Leaflets thickness
At Day 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiac or clinical defects associated with MVP
Time Frame: At Day 0 Follow-up will be carried out at 5 and 10 years
Atrial septal defect, ventricular septal defect, patent ductus arteriosus, tricuspid or aortic valve abnormalities (prolapse, bicuspid AV…), coarctation, ascending aorta aneurysm
At Day 0 Follow-up will be carried out at 5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

University Hospital, Brest
Rennes University Hospital

Investigators

  • Principal Investigator: Vincent Probst, PU-PH, Nantes University Hospital
  • Principal Investigator: Hervé Le Marec, PU-PH, Nantes University Hospital
  • Principal Investigator: Jean-Jacques Schott, DR, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Valve Prolapse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe