<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/NCT02221141</url>
  </required_header>
  <id_info>
    <org_study_id>Fabry Disease Cardioscreening</org_study_id>
    <nct_id>NCT02221141</nct_id>
  </id_info>
  <brief_title>Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laurence Gabriel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire UCLouvain Namur</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the prevalence in Belgium of Fabry disease in&#xD;
      patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to&#xD;
      determine in Fabry patients which was the most frequently initial symptom.&#xD;
&#xD;
      Actually the early diagnosis is important because a treatment exists that can prevent future&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Left Ventricular Hypertrophy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with left ventricular hypertrophy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unexplained left ventricular hypertrophy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  isolated septal hypertrophy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laurence Gabriel</last_name>
    <phone>+32 81 42 21 11</phone>
    <phone_ext>3623</phone_ext>
    <email>laurence.gabriel@uclouvain.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine Jourdan</last_name>
    <phone>+32 81 42 21 11</phone>
    <phone_ext>3610</phone_ext>
    <email>karine.jourdan@uclouvain.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Dinant-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laurence Gabriel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire UCLouvain Namur</investigator_affiliation>
    <investigator_full_name>Laurence Gabriel</investigator_full_name>
    <investigator_title>Dr Laurence GABRIEL</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy, Left Ventricular</mesh_term>
    <mesh_term>Hypertrophy</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/NCT02221141
org study id: Fabry Disease Cardioscreening
nct id: NCT02221141
lead sponsor: 
The purpose of this study is to determine the prevalence in Belgium of Fabry disease in
      patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to
      determine in Fabry patients which was the most frequently initial symptom.

      Actually the early diagnosis is important because a treatment exists that can prevent future
      complications.
observational model: Cohort
time perspective: Other
measure: Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation
time frame: 1 day
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurence Gabriel
phone: +32 81 42 21 11
phone ext: 3623
email: laurence.gabriel@uclouvain.be
last name: Karine Jourdan
phone: +32 81 42 21 11
phone ext: 3610
email: karine.jourdan@uclouvain.be
facility: 
status: Recruiting
investigator: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Universitaire UCLouvain Namur
investigator full name: Laurence Gabriel
investigator title: Dr Laurence GABRIEL
mesh term: Hypertrophy, Left Ventricular
mesh term: Hypertrophy