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Genetic and Phenotypic Characteristics of Mitral Valve Prolapse (MVP)

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ClinicalTrials.gov Identifier: NCT03884426
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
University Hospital, Brest
Rennes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date March 21, 2013
First Posted Date March 21, 2019
Last Update Posted Date March 21, 2019
Study Start Date December 2010
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 19, 2019)
  • Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus) [ Time Frame: At Day 0 ]
    Leaflets length ; Chordae length ; Annulus diameter
  • 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
  • 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
  • Comprehensive mitral valve apparatus characterization per size of items [ Time Frame: At Day 0 ]
    Leaflets thickness
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 19, 2019)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Official Title Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Brief Summary Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.
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
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
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
Condition
  • Mitral Valve Prolapse
  • Genetic Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 19, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of the patient
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Thierry Le Tourneau, PU-PH 0617908670 thletourneau@yahoo.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884426
Other Study ID Numbers RC12_0143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
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
PRS Account Nantes University Hospital
Verification Date March 2019