<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/NCT02193243</url>
  </required_header>
  <id_info>
    <org_study_id>Six-Minute Walk Test</org_study_id>
    <nct_id>NCT02193243</nct_id>
  </id_info>
  <brief_title>Value of 6-minute Walk Test in Grown Ups With Congenital Heart Defects (GUCH)</brief_title>
  <official_title>The Diagnostic Value of Six-Minute Walk Test in Grown-Up Patients With Congenital Heart Disease (GUCH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heinrich-Heine University, Duesseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The six-minute walk test is an established submaximal exercise test. Its role in examination&#xD;
      of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of&#xD;
      this study was a comparison of the 6MWT with other established parameters of functional&#xD;
      capacity, in grown-up patients with GUCH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ranges of six-minute walk distance (6MWD)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Congenital Heart Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient with Congenital Heart Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  congenital heart defect&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental or physical incapability of exercise testing&#xD;
&#xD;
          -  non-cardiac limitations of physical capacity, as e.g. orthopedic diseases or febrile&#xD;
             infections&#xD;
&#xD;
          -  severe psychiatric diseases&#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_official>
    <last_name>Eva S Kehmeier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Cardiology, Pulmonary Disease and Vascular Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malte Kelm, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Division of Cardiology, Pulmonary Disease and Vascular Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>December 14, 2014</last_update_submitted>
  <last_update_submitted_qc>December 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heinrich-Heine University, Duesseldorf</investigator_affiliation>
    <investigator_full_name>Klinik für Kardiologie, Pneumologie und Angiologie</investigator_full_name>
    <investigator_title>Division of Cardiology, Pulmonary Disease and Vascular Medicine</investigator_title>
  </responsible_party>
  <keyword>Congenital Heart Disease</keyword>
  <keyword>Six Minute Walk Test</keyword>
  <keyword>Exercise Testing</keyword>
  <keyword>Peak oxygen uptake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT02193243
org study id: Six-Minute Walk Test
nct id: NCT02193243
lead sponsor: 
has dmc: No
The six-minute walk test is an established submaximal exercise test. Its role in examination
      of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of
      this study was a comparison of the 6MWT with other established parameters of functional
      capacity, in grown-up patients with GUCH.
observational model: Cohort
time perspective: Prospective
measure: Ranges of six-minute walk distance (6MWD)
time frame: Baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eva S Kehmeier, MD
role: Principal Investigator
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
last name: Malte Kelm, MD
role: Study Chair
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heinrich-Heine University, Duesseldorf
investigator full name: Klinik für Kardiologie, Pneumologie und Angiologie
investigator title: Division of Cardiology, Pulmonary Disease and Vascular Medicine
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital