<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/NCT03232671</url>
  </required_header>
  <id_info>
    <org_study_id>15-6529-BO</org_study_id>
    <nct_id>NCT03232671</nct_id>
  </id_info>
  <brief_title>Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure</brief_title>
  <official_title>Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in&#xD;
      cardiovascular diseases when assessed in clinical routine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>180 days mortality</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">180</enrollment>
  <condition>Heart Diseases</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MIF ELISA</intervention_name>
    <description>Blood sample</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting with symptoms of heart failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients presenting with symptoms of heart failure to the West-German Heart and&#xD;
        Vascular Center according to the definition of the ESC 2016.&#xD;
&#xD;
          -  Patients fulfilling criteria for the diagnosis of HFrEF&#xD;
&#xD;
          -  Patients fulfilling criteria for the diagnosis of HFpEF&#xD;
&#xD;
          -  Patients fulfilling criteria for the diagnosis of HFmrEF&#xD;
&#xD;
          -  Patients presenting with dyspnea according to the NYHA classification I-IV, elevated&#xD;
             BNP/NT-proBNP levels and echocardiographic findings of heart failure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patients with symptoms of heart failure without fulfilling the criteria of the ESC&#xD;
             guidelines 2016&#xD;
&#xD;
          -  Denial to participate&#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>Peter Lüdike, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Essen, Department of Cardiology and Vascular medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Essen</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Fadi Al-Rashid</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Diseases</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/NCT03232671
org study id: 15-6529-BO
nct id: NCT03232671
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in
      cardiovascular diseases when assessed in clinical routine.
observational model: Case-Control
time perspective: Prospective
measure: 180 days mortality
time frame: 180 days
intervention type: Diagnostic Test
intervention name: MIF ELISA
description: Blood sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Lüdike, M.D.
role: Principal Investigator
affiliation: University Hospital of Essen, Department of Cardiology and Vascular medicine
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Fadi Al-Rashid
investigator title: Dr.
mesh term: Heart Failure
mesh term: Heart Diseases
sharing ipd: No