Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Genetic Disease Clinical Trial

— MVP  

Official title:

Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884426
• Other study ID #: RC12_0143
• Status: Recruiting
• Start date: December 2010
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Nantes University Hospital
• Contact: Thierry Le Tourneau, PU-PH
• Phone: 0617908670
• Email: thletourneau[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients of any age

• with typical mitral valve prolapse

• relatives examined during familial screening

Exclusion Criteria:

• Refusal of the patient

Related Conditions & MeSH terms

• Genetic Disease
• Genetic Diseases, Inborn
• Mitral Valve Prolapse
• Prolapse

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Rennes University Hospital, University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of cardiac or clinical defects associated with MVP	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
Primary	MVP defined by a superior displacement of at least 2 mm	MVP defined by a superior displacement of at least 2 mm	At Day 0
Secondary	Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)	Leaflets length ; Chordae length ; Annulus diameter	At Day 0
Secondary	Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)	Papillary muscles aspect ; Right Ventricle function ; Left Ventricle Ejection Fraction	At Day 0
Secondary	Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)	Left ventricle and atrium sizes ; right ventricle size ; right Atrium size	At Day 0
Secondary	Comprehensive mitral valve apparatus characterization per size of items	Leaflets thickness	At Day 0