Genetic Basis of Mitral Valve Prolapse | NCT01719211

Studies
Genetic Basis of Mitral Valve Prolapse

NCT01719211

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Nov 8, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Mitral Valve Prolapse

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Oct 30, 2012

First Submission Date that Met QC Criteria

Oct 31, 2012

First Posted Date

Nov 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 8, 2023Actual

Name	Class
Leducq Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions. This requires recruiting large families who may have MVP linked to these or other chromosomes; and obtaining DNA samples from 1,000-1,500 individually affected patients to study the relation between DNA markers throughout the genome and MVP. It is our expectation that the results of this study will lead to the discovery of gene(s) responsible for MVP. This will lead to improved understanding of the disease and, in turn, improved ability to treat and prevent progression in genetically susceptible individuals.

Detailed Description

This is a genome-wide association study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discovery of the genetic basis of Mitral Valve Prolapse	Genome-wide association	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mitral valve prolapse

Exclusion Criteria:

Other mitral valve diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients referred for 2D echo for MVP

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Susan Slaugenhaupt, PhD	Contact	6176433217		slaugenhaupt@chgr.mgh.harvard.edu
Robert a levine, MD	Contact	6177241995		rlevine@partners.org

Overall Officials

Name	Affiliation	Role
robert a levine, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mass General Hospital	Recruiting	Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D008945	Mitral Valve Prolapse

Ancestor Terms

ID	Term
D016127	Heart Valve Prolapse
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided