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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

Study Description
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Brief Summary:
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Condition or disease
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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Study Start Date : December 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus) [ Time Frame: At Day 0 ]
    Leaflets length ; Chordae length ; Annulus diameter

  2. 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

  3. 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

  4. Comprehensive mitral valve apparatus characterization per size of items [ Time Frame: At Day 0 ]
    Leaflets thickness


Other Outcome Measures:
  1. 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


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884426


Contacts
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Contact: Thierry Le Tourneau, PU-PH 0617908670 thletourneau@yahoo.fr

Locations
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France
Brest University Hospital Not yet recruiting
Brest, France, 29200
Contact: Jacques Mansourati, PU-PH    02 98 34 73 91    jacques.mansourati@chu-brest.fr   
Sub-Investigator: Yves Etienne, PH         
Sub-Investigator: Yannick Jobic, PH         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Thierry Le Tourneau, PU-PH    0617908670    thletourneau@yahoo.fr   
Principal Investigator: Thierry Le Tourneau, PU-PH         
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Erwan Donal, PU-PH    02 99 28 25 27    erwan.donal@chu-rennes.fr   
Principal Investigator: Erwan Donal, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
University Hospital, Brest
Rennes University Hospital
Investigators
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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
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03884426    
Other Study ID Numbers: RC12_0143
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Nantes University Hospital:
Mitral valve prolapse
genetic
echocardiography
Additional relevant MeSH terms:
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Mitral Valve Prolapse
Genetic Diseases, Inborn
Prolapse
Pathological Conditions, Anatomical
 Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases