<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/NCT02971267</url>
  </required_header>
  <id_info>
    <org_study_id>SFB/TR19plus-001</org_study_id>
    <nct_id>NCT02971267</nct_id>
  </id_info>
  <brief_title>Follow-up of the Cardiomyopathy Cohort SFB/TR19</brief_title>
  <acronym>SFB/TR19plus</acronym>
  <official_title>Follow-up of the Inflammatory Cardiomyopathy Cohort of 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>
      Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated&#xD;
      inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized&#xD;
      protocols will be used for the assessment of medical history and examinations, laboratory&#xD;
      biomarkers, and the collection of various biomaterials for biobanking purposes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or&#xD;
      validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project.&#xD;
      Participants will be followed up at least every year - or more frequently based on clinical&#xD;
      need. Standardized protocols will be used for the assessment of medical history and&#xD;
      examinations, laboratory biomarkers, and the collection of various biomaterials for&#xD;
      biobanking purposes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">December 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cardiovascular events</measure>
    <time_frame>1-year follow-ups up to 10 years</time_frame>
    <description>Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LVEF (left ventricular ejection fraction)</measure>
    <time_frame>1-year follow-ups up to 10 years</time_frame>
    <description>Left ventricular ejection fraction at time of follow-ups (through study completion, every year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2peak</measure>
    <time_frame>1-year follow-ups up to 10 years</time_frame>
    <description>Exercise capacity by CPET (cardiopulmonary exercise testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL</measure>
    <time_frame>1-year follow-ups up to 10 years</time_frame>
    <description>Quality of life by MLHF questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1-year follow-ups up to 10 years</time_frame>
    <description>Mortality (HF-related, cardiovascular disease, all-cause mortality)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>None, observational only</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <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;
          -  Participation in baseline examination of SFB/TR19&#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_contact>
    <last_name>Marcus Dörr, MD</last_name>
    <phone>+49383486</phone>
    <phone_ext>80500</phone_ext>
    <email>mdoerr@uni-greifswald.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stephan B Felix, MD</last_name>
    <phone>+49383486</phone>
    <phone_ext>80500</phone_ext>
    <email>felix@uni-greifswald.de</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcus Dörr, MD</last_name>
      <phone>+49383486</phone>
      <phone_ext>80500</phone_ext>
      <email>mdoerr@uni-greifswald.de</email>
    </contact>
    <contact_backup>
      <last_name>Stephan B Felix, MD</last_name>
      <phone>+49383486</phone>
      <phone_ext>80500</phone_ext>
      <email>felix@uni-greifswald.de</email>
    </contact_backup>
    <investigator>
      <last_name>Kristin Lehnert, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sabine Kaczmarek, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ann Louise Pedersen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>cardiomyopathy</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/NCT02971267
org study id: SFB/TR19plus-001
nct id: NCT02971267
lead sponsor: 
has dmc: No
Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated
      inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized
      protocols will be used for the assessment of medical history and examinations, laboratory
      biomarkers, and the collection of various biomaterials for biobanking purposes.
Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or
      validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project.
      Participants will be followed up at least every year - or more frequently based on clinical
      need. Standardized protocols will be used for the assessment of medical history and
      examinations, laboratory biomarkers, and the collection of various biomaterials for
      biobanking purposes.
observational model: Cohort
time perspective: Prospective
measure: Number of cardiovascular events
time frame: 1-year follow-ups up to 10 years
description: Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction
measure: LVEF (left ventricular ejection fraction)
time frame: 1-year follow-ups up to 10 years
description: Left ventricular ejection fraction at time of follow-ups (through study completion, every year)
measure: VO2peak
time frame: 1-year follow-ups up to 10 years
description: Exercise capacity by CPET (cardiopulmonary exercise testing)
measure: QOL
time frame: 1-year follow-ups up to 10 years
description: Quality of life by MLHF questionnaire
measure: Mortality
time frame: 1-year follow-ups up to 10 years
description: Mortality (HF-related, cardiovascular disease, all-cause mortality)
intervention type: Other
intervention name: Observational
description: None, observational only
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus Dörr, MD
phone: +49383486
phone ext: 80500
email: mdoerr@uni-greifswald.de
last name: Stephan B Felix, MD
phone: +49383486
phone ext: 80500
email: felix@uni-greifswald.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiomyopathies
sharing ipd: No