<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719211</url>
  </required_header>
  <id_info>
    <org_study_id>1999-p-007948</org_study_id>
    <nct_id>NCT01719211</nct_id>
  </id_info>
  <brief_title>Genetic Basis of Mitral Valve Prolapse</brief_title>
  <acronym>MVP</acronym>
  <official_title>Genetic Basis of Mitral Valve Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leducq Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have successfully identified two novel genetic loci for MVP on chromosomes&#xD;
      11 and 13 and are searching for altered genes in these regions. This requires recruiting&#xD;
      large families who may have MVP linked to these or other chromosomes; and obtaining DNA&#xD;
      samples from 1,000-1,500 individually affected patients to study the relation between DNA&#xD;
      markers throughout the genome and MVP. It is our expectation that the results of this study&#xD;
      will lead to the discovery of gene(s) responsible for MVP. This will lead to improved&#xD;
      understanding of the disease and, in turn, improved ability to treat and prevent progression&#xD;
      in genetically susceptible individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a genome-wide association study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 1999</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Discovery of the genetic basis of Mitral Valve Prolapse</measure>
    <time_frame>5 years</time_frame>
    <description>Genome-wide association</description>
  </primary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Mitral Valve Prolapse</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred for 2D echo for MVP&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mitral valve prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other mitral valve diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>robert a levine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mass. General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susan Slaugenhaupt, PhD</last_name>
    <phone>6176433217</phone>
    <email>slaugenhaupt@chgr.mgh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert a levine, MD</last_name>
    <phone>6177241995</phone>
    <email>rlevine@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mass General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Robert A. Levine, MD</investigator_full_name>
    <investigator_title>Cardiologist</investigator_title>
  </responsible_party>
  <keyword>MVP, mitral valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Prolapse</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719211
org study id: 1999-p-007948
nct id: NCT01719211
lead sponsor: 
collaborator: 
has dmc: No
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.
This is a genome-wide association study.
observational model: Other
time perspective: Prospective
measure: Discovery of the genetic basis of Mitral Valve Prolapse
time frame: 5 years
description: Genome-wide association
DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: robert a levine, MD
role: Principal Investigator
affiliation: Mass. General Hospital
last name: Susan Slaugenhaupt, PhD
phone: 6176433217
email: slaugenhaupt@chgr.mgh.harvard.edu
last name: Robert a levine, MD
phone: 6177241995
email: rlevine@partners.org
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Robert A. Levine, MD
investigator title: Cardiologist
mesh term: Mitral Valve Prolapse
mesh term: Prolapse