<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/NCT02258724</url>
  </required_header>
  <id_info>
    <org_study_id>EKBB 180/13</org_study_id>
    <nct_id>NCT02258724</nct_id>
  </id_info>
  <brief_title>Swiss National Registry of Grown up Congenital Heart Disease Patients</brief_title>
  <acronym>GUCH</acronym>
  <official_title>Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the&#xD;
      children with congenital heart disease reach adult age.This results in an increasing number&#xD;
      of adults or &quot;grown-ups&quot; with congenital heart disease (ACHD or GUCH patients) that require&#xD;
      special health care organization and training programmes. Long term complications of these&#xD;
      GUCH patients and optimum treatment strategies are still poorly known. The aim of this&#xD;
      registry is to collect quantitative and qualitative data regarding GUCH patients treated in&#xD;
      specialised centres in Switzerland.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SWISS GUCH registry will capture epidemiologic data, diagnosis, type of earlier treatment&#xD;
      / intervention and cardiac complications. Following each visit, the cardiac complications&#xD;
      will be captured as well as the mortality.&#xD;
&#xD;
      Every GUCH patient coming for a visit in one of the specialized organisation participating to&#xD;
      the registry will be asked to participate. After signing the informed consent form, the&#xD;
      patient data will be coded and captured in a web-based data base (secuTrial®).&#xD;
&#xD;
      Pooling the data from the different centres will enable a nation wide register to be&#xD;
      established. More robust data on the size and composition of the GUCH population will be&#xD;
      obtained. Also long term prognosis of specific patient group will be derived.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">December 2033</completion_date>
  <primary_completion_date type="Anticipated">December 2033</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year and yearly up to 20 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardial complications</measure>
    <time_frame>1 year and yearly up to 20 years</time_frame>
    <description>Requiring in-patient hospitalisation, strokes, re-intervention</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Congenital Heart Defect</condition>
  <eligibility>
    <study_pop>
      <textblock>
        GUCH patient treated in one of the Swiss centre with specialized organisation GUCH&#xD;
        (University Hospital Basel, University Hospital Zurich, University Hospital Lausanne,&#xD;
        University Hospital Geneva, Canton Hospital StGallen).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult (above 18 years of age) with congenital heart disease, treated in one of the Swiss&#xD;
        centre with specialized organisation for GUCH patients.&#xD;
&#xD;
        Signed informed consent. Patients with trisomy 21: the parents or legal guardian will have&#xD;
        to give the consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#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>Daniel Tobler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Tobler, MD</last_name>
    <phone>+41 61 265 52 14</phone>
    <email>daniel.tobler@usb.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Basel University Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Tobler, MD</last_name>
      <phone>+41 61 265 52 14</phone>
      <email>daniel.tobler@usb.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bern University Hospital Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Schwerzmann, Prof. MD</last_name>
      <phone>+41 31 632 7859</phone>
      <email>markus.schwerzmann@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Kerstin Wustmann, MD</last_name>
      <phone>+41 31 632 21 11</phone>
      <phone_ext>7679</phone_ext>
      <email>Kerstin.Wustmann@insel.ch</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève HUG</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Judith Bouchardy, MD</last_name>
      <phone>+41 22 372 75 31</phone>
      <email>judith.bouchardy@hcuge.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois CHUV</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Judith Bouchardy, MD</last_name>
      <phone>+41 79 55 65 467</phone>
      <email>judith.bouchardy@chuv.ch</email>
    </contact>
    <contact_backup>
      <last_name>Tobias Rutz, MD</last_name>
      <phone>+41 79 55 670 33</phone>
      <email>tobias.rutz@chuv.ch</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St.Gallen</name>
      <address>
        <city>St Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominik Stambach, MD</last_name>
      <phone>+41 71 494 10 51</phone>
      <email>dominik.stambach@kispisg.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Greutmann, MD</last_name>
      <phone>+41 44 255 38 83</phone>
      <email>Matthias.Greutmann@usz.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.</citation>
    <PMID>21098444</PMID>
  </reference>
  <reference>
    <citation>Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.</citation>
    <PMID>12084585</PMID>
  </reference>
  <reference>
    <citation>van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.</citation>
    <PMID>22078432</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adult</keyword>
  <keyword>Registry</keyword>
  <keyword>Grown-up congenital heart disease</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/NCT02258724
org study id: EKBB 180/13
nct id: NCT02258724
lead sponsor: 
has dmc: No
Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the
      children with congenital heart disease reach adult age.This results in an increasing number
      of adults or "grown-ups" with congenital heart disease (ACHD or GUCH patients) that require
      special health care organization and training programmes. Long term complications of these
      GUCH patients and optimum treatment strategies are still poorly known. The aim of this
      registry is to collect quantitative and qualitative data regarding GUCH patients treated in
      specialised centres in Switzerland.
The SWISS GUCH registry will capture epidemiologic data, diagnosis, type of earlier treatment
      / intervention and cardiac complications. Following each visit, the cardiac complications
      will be captured as well as the mortality.

      Every GUCH patient coming for a visit in one of the specialized organisation participating to
      the registry will be asked to participate. After signing the informed consent form, the
      patient data will be coded and captured in a web-based data base (secuTrial®).

      Pooling the data from the different centres will enable a nation wide register to be
      established. More robust data on the size and composition of the GUCH population will be
      obtained. Also long term prognosis of specific patient group will be derived.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 1 year and yearly up to 20 years
measure: Cardial complications
time frame: 1 year and yearly up to 20 years
description: Requiring in-patient hospitalisation, strokes, re-intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Tobler, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Daniel Tobler, MD
phone: +41 61 265 52 14
email: daniel.tobler@usb.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.
PMID: 21098444
citation: Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
PMID: 12084585
citation: van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
PMID: 22078432
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital