Genetic and Phenotypic Characteristics of Mitral Valve Prolapse (MVP)
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| ClinicalTrials.gov Identifier: NCT03884426 |
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Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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Sponsor:
Nantes University Hospital
Collaborators:
University Hospital, Brest
Rennes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
| Tracking Information | ||||||||||
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| 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 |
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
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
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
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| 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 |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood
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| 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 |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts |
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| 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 |
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| Investigators |
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| PRS Account | Nantes University Hospital | |||||||||
| Verification Date | March 2019 | |||||||||