<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/NCT02970214</url>
  </required_header>
  <id_info>
    <org_study_id>GANIFU-C-001</org_study_id>
    <nct_id>NCT02970214</nct_id>
  </id_info>
  <brief_title>Follow-up of GANI_MED Cardio Cohorts</brief_title>
  <acronym>GANIFU-Card</acronym>
  <official_title>Greifswald Approach to Individualized Medicine (GANI_MED) - Follow-up of Cardiovascular Cohorts</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 two hospital-based patient cohorts (heart failure, metabolic comorbidities in&#xD;
      CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized&#xD;
      Medicine). Standardized protocols will be used for the assessment of medical history,&#xD;
      laboratory biomarkers, and the collection of various biosamples for bio-banking purposes.&#xD;
      Comparisons with the general background population will be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      5-year follow-up of two hospital-based patient cohorts (heart failure, metabolic&#xD;
      comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to&#xD;
      Individualized Medicine). Subjects will be comprehensively phenotypes using standardized&#xD;
      protocols for the assessment of medical history, laboratory biomarkers, and the collection of&#xD;
      various biosamples for bio-banking purposes. A multi-omics based biomarker assessment&#xD;
      including genome-wide genotyping, transcriptome, metabolome, and proteome analyses&#xD;
      complements the multi-level approach of GANI_MED. Comparisons with the general background&#xD;
      population as characterized by the Study of Health in Pomerania (SHIP) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Hospitalization (HF based. all-cause), myocardial infarction</description>
  </primary_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 heart failure questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6MW</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>6 minute walk test distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEF</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>Left ventricular ejection fraction by echo at time of follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>PWA</measure>
    <time_frame>1-year follow-ups</time_frame>
    <description>pulse wave analysis parameters by Vascular Explorer device (neverdis GmbH, Germany)</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Chronic Heart Failure</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <description>Patients with chronic heart failure and with/without reduced left ventricular ejection fraction (EF) at baseline (HFrEF, HFmrEF, HFpEF)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiometabolic risk</arm_group_label>
    <description>Patients with cardiovascular diseases and metabolic risk factors at baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention, only observational</intervention_name>
    <description>no intervention, only observational</description>
    <arm_group_label>Cardiometabolic risk</arm_group_label>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients included into the baseline examinations of the two cohorts&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic&#xD;
             risk)&#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 Lousie Pedersen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www2.medizin.uni-greifswald.de/gani_med/index.php?id=603&amp;L=1</url>
    <description>Homepage of GANI_MED project</description>
  </link>
  <reference>
    <citation>Grabe HJ, Assel H, Bahls T, Dorr M, Endlich K, Endlich N, Erdmann P, Ewert R, Felix SB, Fiene B, Fischer T, Flessa S, Friedrich N, Gadebusch-Bondio M, Salazar MG, Hammer E, Haring R, Havemann C, Hecker M, Hoffmann W, Holtfreter B, Kacprowski T, Klein K, Kocher T, Kock H, Krafczyk J, Kuhn J, Langanke M, Lendeckel U, Lerch MM, Lieb W, Lorbeer R, Mayerle J, Meissner K, zu Schwabedissen HM, Nauck M, Ott K, Rathmann W, Rettig R, Richardt C, Salje K, Schminke U, Schulz A, Schwab M, Siegmund W, Stracke S, Suhre K, Ueffing M, Ungerer S, Volker U, Volzke H, Wallaschofski H, Werner V, Zygmunt MT, Kroemer HK. Cohort profile: Greifswald approach to individualized medicine (GANI_MED). J Transl Med. 2014 May 23;12:144. doi: 10.1186/1479-5876-12-144.</citation>
    <PMID>24886498</PMID>
  </reference>
  <verification_date>September 2021</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>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>heart disease</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>metabolic risk</keyword>
  <keyword>comorbidities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT02970214
org study id: GANIFU-C-001
nct id: NCT02970214
lead sponsor: 
has dmc: No
Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in
      CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized
      Medicine). Standardized protocols will be used for the assessment of medical history,
      laboratory biomarkers, and the collection of various biosamples for bio-banking purposes.
      Comparisons with the general background population will be performed.
5-year follow-up of two hospital-based patient cohorts (heart failure, metabolic
      comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to
      Individualized Medicine). Subjects will be comprehensively phenotypes using standardized
      protocols for the assessment of medical history, laboratory biomarkers, and the collection of
      various biosamples for bio-banking purposes. A multi-omics based biomarker assessment
      including genome-wide genotyping, transcriptome, metabolome, and proteome analyses
      complements the multi-level approach of GANI_MED. Comparisons with the general background
      population as characterized by the Study of Health in Pomerania (SHIP) will be performed.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular events
time frame: 1-year follow-ups
description: Hospitalization (HF based. all-cause), myocardial infarction
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 heart failure questionnaire)
measure: 6MW
time frame: 1-year follow-ups
description: 6 minute walk test distance
measure: LVEF
time frame: 1-year follow-ups
description: Left ventricular ejection fraction by echo at time of follow-up
measure: PWA
time frame: 1-year follow-ups
description: pulse wave analysis parameters by Vascular Explorer device (neverdis GmbH, Germany)
arm group label: Heart Failure
description: Patients with chronic heart failure and with/without reduced left ventricular ejection fraction (EF) at baseline (HFrEF, HFmrEF, HFpEF)
arm group label: Cardiometabolic risk
description: Patients with cardiovascular diseases and metabolic risk factors at baseline
intervention type: Other
intervention name: no intervention, only observational
description: no intervention, only observational
arm group label: Cardiometabolic risk
arm group label: Heart Failure
blood, urine
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
url: http://www2.medizin.uni-greifswald.de/gani_med/index.php?id=603&L=1
description: Homepage of GANI_MED project
citation: Grabe HJ, Assel H, Bahls T, Dorr M, Endlich K, Endlich N, Erdmann P, Ewert R, Felix SB, Fiene B, Fischer T, Flessa S, Friedrich N, Gadebusch-Bondio M, Salazar MG, Hammer E, Haring R, Havemann C, Hecker M, Hoffmann W, Holtfreter B, Kacprowski T, Klein K, Kocher T, Kock H, Krafczyk J, Kuhn J, Langanke M, Lendeckel U, Lerch MM, Lieb W, Lorbeer R, Mayerle J, Meissner K, zu Schwabedissen HM, Nauck M, Ott K, Rathmann W, Rettig R, Richardt C, Salje K, Schminke U, Schulz A, Schwab M, Siegmund W, Stracke S, Suhre K, Ueffing M, Ungerer S, Volker U, Volzke H, Wallaschofski H, Werner V, Zygmunt MT, Kroemer HK. Cohort profile: Greifswald approach to individualized medicine (GANI_MED). J Transl Med. 2014 May 23;12:144. doi: 10.1186/1479-5876-12-144.
PMID: 24886498
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Metabolic Syndrome
sharing ipd: No