MVP: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03884426

Collaborator

University Hospital, Brest (Other), Rennes University Hospital (Other)

1,000

Enrollment

Locations

132

Anticipated Duration (Months)

333.3

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Prolapse Genetic Disease

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Actual Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

MVP defined by a superior displacement of at least 2 mm [At Day 0]
MVP defined by a superior displacement of at least 2 mm

Secondary Outcome Measures

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

Other Outcome Measures

Incidence of cardiac or clinical defects associated with MVP [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Refusal of the patient

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Brest University Hospital	Brest	France	29200
2	Nantes University Hospital	Nantes	France	44093
3	Rennes University Hospital	Rennes	France	35033

Sponsors and Collaborators

Nantes University Hospital
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