<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/NCT03021213</url>
  </required_header>
  <id_info>
    <org_study_id>EECP</org_study_id>
    <nct_id>NCT03021213</nct_id>
  </id_info>
  <brief_title>Treating Heart Failure With Enhanced External Counterpulsation (EECP)</brief_title>
  <official_title>Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD)&#xD;
      therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower&#xD;
      extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New&#xD;
      York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Systolic and diastolic heart function</measure>
    <time_frame>A period of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ergometric power increase</measure>
    <time_frame>A period of 1 year</time_frame>
    <description>Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective health Status - Mental Health Composite Score</measure>
    <time_frame>A period of 1 year</time_frame>
    <description>Sf-12-questionnaire: value of the Mental Health Composite Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective health Status - Physical Health Composite Score</measure>
    <time_frame>A period of 1 year</time_frame>
    <description>Sf-12-questionnaire: value of the Physical Health Composite Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ complications</measure>
    <time_frame>A period of 1 year</time_frame>
    <description>Relevant laboratory parameters</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with heart failure (NYHA II-IV)&#xD;
&#xD;
          -  with optimal medical therapy&#xD;
&#xD;
          -  arisen from ischemic or non-ischemic cardiomyopathy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with heart failure (NYHA II-IV)&#xD;
&#xD;
               1. with optimal medical therapy&#xD;
&#xD;
               2. caused by ischemic or non-ischemic cardiomyopathy&#xD;
&#xD;
          -  EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University&#xD;
             Medicine Berlin&#xD;
&#xD;
          -  Aged 18 to 100 years&#xD;
&#xD;
          -  Offered patient information and written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another interventional trial&#xD;
&#xD;
          -  Acute coronary syndrome &lt; 4 weeks prior to enrollment&#xD;
&#xD;
          -  Operation &lt; 4 weeks prior to enrollment&#xD;
&#xD;
          -  Stroke &lt; 4 weeks prior to enrollment&#xD;
&#xD;
          -  Clinically significant disease with hospitalization&#xD;
&#xD;
          -  Aortic valvular heart disease ≥ moderate&#xD;
&#xD;
          -  Aortic aneurysm&#xD;
&#xD;
          -  clinically relevant severe cardiopulmonal diseases&#xD;
&#xD;
          -  Resting RR &gt; 160/90mmHg&#xD;
&#xD;
          -  Thrombose, Thrombophlebitis &lt; 8 weeks prior to enrollment&#xD;
&#xD;
          -  Peripheral artery occlusive disease ≥ Stadium II&#xD;
&#xD;
          -  Acute Heart failure&#xD;
&#xD;
          -  Pathological bleeding tendency&#xD;
&#xD;
          -  Arrhythmias, which interfere with Triggering of the EECP&#xD;
&#xD;
          -  Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  Women: pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Spies, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Campus Virchow - Klinikum, Charité - University Medicine Berlin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03021213
org study id: EECP
nct id: NCT03021213
lead sponsor: 
has dmc: No
Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD)
      therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower
      extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New
      York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.
observational model: Cohort
time perspective: Prospective
measure: Systolic and diastolic heart function
time frame: A period of 1 year
measure: Ergometric power increase
time frame: A period of 1 year
description: Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt.
measure: Subjective health Status - Mental Health Composite Score
time frame: A period of 1 year
description: Sf-12-questionnaire: value of the Mental Health Composite Score
measure: Subjective health Status - Physical Health Composite Score
time frame: A period of 1 year
description: Sf-12-questionnaire: value of the Physical Health Composite Score
measure: Organ complications
time frame: A period of 1 year
description: Relevant laboratory parameters
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Claudia Spies, MD, Prof.
role: Study Director
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Campus Virchow - Klinikum, Charité - University Medicine Berlin
mesh term: Heart Failure
sharing ipd: No