Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03884426
Other study ID # RC12_0143
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03292302 - Phase 1 Study of ELX-02 in Healthy Adults Phase 1
Withdrawn NCT03658382 - Virtual Visits for Results Disclosure N/A
Recruiting NCT02266615 - Biobank Clinical Genetics Maastricht (KG01)
Recruiting NCT02450851 - Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases Network
Recruiting NCT05472714 - Educational Video for Genetic Testing N/A
Recruiting NCT04285814 - Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood
Completed NCT05443113 - Young Pectus Excavatum Patients and Genetic Defects
Completed NCT05655741 - Modified Delphi for Genomic Bereavement Care
Completed NCT03847909 - A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 Phase 2
Completed NCT04584528 - Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease N/A
Not yet recruiting NCT06048523 - Prospective Cohort Study of Neurogenetic Diseases N/A
Completed NCT02225522 - Genomic Sequencing in Acutely Ill Neonates N/A
Enrolling by invitation NCT06089954 - Penn Medicine Biobank Return of Results Program N/A
Completed NCT03713333 - Implementing Digital Health in a Learning Health System N/A
Completed NCT03309605 - Phase 1 Study of ELX-02 in Healthy Adult Subjects Phase 1
Recruiting NCT05499091 - Functional Study to Indentify Genetic Etiology of Rare Diseases - ORIGIN N/A
Completed NCT04556487 - Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Completed NCT04556500 - Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
Recruiting NCT02551081 - Genomic Sequencing and Personalized Treatment for Birth Defects in Neonatal Intensive Care Units