<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/NCT02187263</url>
  </required_header>
  <id_info>
    <org_study_id>DZHK TORCH 001</org_study_id>
    <nct_id>NCT02187263</nct_id>
  </id_info>
  <brief_title>German Centre for Cardiovascular Research Cardiomyopathy Register</brief_title>
  <acronym>TORCH</acronym>
  <official_title>DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kerckhoff Klinik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Goettingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Luebeck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mainz University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Centre Mannheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Hannover</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department for Community Medicine, University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Goethe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Greifswald</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ISAR Klinikum Munich</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a joint project by Heidelberg University and Greifswald University.&#xD;
&#xD;
      Our objective is to establish an unique national multi-center registry and biobank of well&#xD;
      phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,&#xD;
      molecular and omics-based phenotyping to serve as:&#xD;
&#xD;
        1. central hub for clinical outcome studies.&#xD;
&#xD;
        2. joint resource for diagnostic and therapeutic trials.&#xD;
&#xD;
        3. common biomaterial bank.&#xD;
&#xD;
        4. resource for detailed molecular analyses on patients' biomaterials and patient specific&#xD;
           model systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following basic research projects, called modules, will be tied to and rely on the&#xD;
      recruitment of CMP patients and the infrastructure provided by TORCH:&#xD;
&#xD;
        -  Well phenotyped patients will be the starting point for comprehensive next-generation&#xD;
           genotyping, leading to advanced estimates of genotype-phenotype relationship and its&#xD;
           clinical impact.&#xD;
&#xD;
        -  Functional analysis of novel genomic loci and their related molecular pathways will be&#xD;
           based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g.&#xD;
           zebrafish and mice) model systems.&#xD;
&#xD;
        -  The integrated analysis of viral load and replication, inflammation, genotype and&#xD;
           clinical variables will define risk variables for inflammatory and hereditary CMP.&#xD;
&#xD;
        -  By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic,&#xD;
           molecular biomarkers and histopathology for diagnosis and out-come prediction will be&#xD;
           defined on a national level.&#xD;
&#xD;
      The registry will also facilitate investigator initiated clinical trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">2300</enrollment>
  <condition>Acute Myocarditis</condition>
  <condition>Dilated Cardiomyopathies</condition>
  <condition>Hypertrophic Cardiomyopathies</condition>
  <condition>Left Ventricular Myocardial Noncompaction Cardiomyopathy</condition>
  <condition>Arrhythmogenic Right Ventricular Cardiomyopathies</condition>
  <condition>Amyloidosis</condition>
  <arm_group>
    <arm_group_label>hereditary DCM</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>inflammatory DCM</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>LVNC</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>HCM</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ARVC</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>acute myocarditis</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA, serum, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hereditary and inflammatory cardiomyopathies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with primary non-ischemic cardiomyopathies including hereditary and&#xD;
             inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy,&#xD;
             hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and&#xD;
             acute myocarditis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting other cardiac diseases such as significant valvular, ischemic or&#xD;
             pericardial disease; Severe arterial hypertension; Primary pulmonary artery&#xD;
             hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents&#xD;
             and chest radiation; Drug and alcohol abuse; Patients &lt;18 and &gt;79 years of age; Life&#xD;
             expectancy less than 1 year due to non-cardiac comorbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugo A Katus, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Heidelberg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wolfgang Hoffmann, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department for Community Medicine, University Medicine Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas O Doesch, MD</last_name>
      <phone>49 622156</phone>
      <phone_ext>39936</phone_ext>
      <email>Andreas.Doesch@med.uni-heidelberg.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 24, 2016</last_update_submitted>
  <last_update_submitted_qc>March 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hereditary cardiomyopathy,</keyword>
  <keyword>inflammatory cardiomyopathy,</keyword>
  <keyword>registry,</keyword>
  <keyword>biomaterial,</keyword>
  <keyword>clinical trial</keyword>
  <keyword>Patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Arrhythmogenic Right Ventricular Dysplasia</mesh_term>
    <mesh_term>Amyloidosis</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/NCT02187263
org study id: DZHK TORCH 001
nct id: NCT02187263
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a joint project by Heidelberg University and Greifswald University.

      Our objective is to establish an unique national multi-center registry and biobank of well
      phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,
      molecular and omics-based phenotyping to serve as:

        1. central hub for clinical outcome studies.

        2. joint resource for diagnostic and therapeutic trials.

        3. common biomaterial bank.

        4. resource for detailed molecular analyses on patients' biomaterials and patient specific
           model systems.
The following basic research projects, called modules, will be tied to and rely on the
      recruitment of CMP patients and the infrastructure provided by TORCH:

        -  Well phenotyped patients will be the starting point for comprehensive next-generation
           genotyping, leading to advanced estimates of genotype-phenotype relationship and its
           clinical impact.

        -  Functional analysis of novel genomic loci and their related molecular pathways will be
           based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g.
           zebrafish and mice) model systems.

        -  The integrated analysis of viral load and replication, inflammation, genotype and
           clinical variables will define risk variables for inflammatory and hereditary CMP.

        -  By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic,
           molecular biomarkers and histopathology for diagnosis and out-come prediction will be
           defined on a national level.

      The registry will also facilitate investigator initiated clinical trials.
observational model: Cohort
time perspective: Prospective
measure: Time to Disease Progression
time frame: 12 months
arm group label: hereditary DCM
arm group label: inflammatory DCM
arm group label: LVNC
arm group label: HCM
arm group label: ARVC
arm group label: acute myocarditis
EDTA, serum, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Hugo A Katus, MD
role: Study Chair
affiliation: Heidelberg University
last name: Wolfgang Hoffmann, MD
role: Study Chair
affiliation: Department for Community Medicine, University Medicine Greifswald
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Cardiomyopathy, Dilated
mesh term: Myocarditis
mesh term: Arrhythmogenic Right Ventricular Dysplasia
mesh term: Amyloidosis