<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/NCT02970227</url>
  </required_header>
  <id_info>
    <org_study_id>SFB/TR19-001</org_study_id>
    <nct_id>NCT02970227</nct_id>
  </id_info>
  <brief_title>Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19)</brief_title>
  <acronym>SFB/TR19</acronym>
  <official_title>Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte &quot;Entzündliche Kardiomyopathien&quot; Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy)&#xD;
      recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment&#xD;
      of medical history and examinations, laboratory biomarkers, and the collection of various&#xD;
      biosamples for biobanking purposes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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 Years</target_duration>
  <primary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LVEF</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Left ventricular ejection fraction at time of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2peak</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Exercise capacity by CPET</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Quality of life by questionnaire (Minnesota Living with HF questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Mortality (HF-related, CVD, all-cause)</description>
  </secondary_outcome>
  <enrollment type="Actual">920</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>None, observation only</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected or validated inflammatory cardiomyopathy at baseline&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suspected inflammatory cardiomyopathy at baseline&#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>
  <location>
    <facility>
      <name>Department of Internal Medicine B, University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <state>MV</state>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>cardiomyopathies</keyword>
  <keyword>myocarditis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02970227
org study id: SFB/TR19-001
nct id: NCT02970227
lead sponsor: 
has dmc: No
cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy)
      recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment
      of medical history and examinations, laboratory biomarkers, and the collection of various
      biosamples for biobanking purposes.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular events
time frame: 1-year follow-ups
description: Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
measure: LVEF
time frame: 1-year follow-ups
description: Left ventricular ejection fraction at time of follow-up
measure: VO2peak
time frame: 1-year follow-ups
description: Exercise capacity by CPET
measure: QOL
time frame: 1-year follow-ups
description: Quality of life by questionnaire (Minnesota Living with HF questionnaire)
measure: Mortality
time frame: 1-year follow-ups
description: Mortality (HF-related, CVD, all-cause)
intervention type: Other
intervention name: Observation
description: None, observation only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiomyopathies
sharing ipd: No