<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/NCT01698398</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2012-092</org_study_id>
    <nct_id>NCT01698398</nct_id>
  </id_info>
  <brief_title>The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device</brief_title>
  <official_title>The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the relationship between working capacity (peak oxygen&#xD;
      consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in&#xD;
      heart failure patients. The hypothesis is that it is possible to increase peak oxygen&#xD;
      consumption by incrementally increasing CF-LVAD pumpspeed during exercise.&#xD;
&#xD;
      The study population will consist of severe heart failure patients with CF-LVADs treated at&#xD;
      The Heart Centre of Copenhagen University Hospital Rigshospitalet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak oxygen consumption.</measure>
    <time_frame>Day 1</time_frame>
    <description>ml oxygen/minute/kg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Working capacity.</measure>
    <time_frame>Day 1</time_frame>
    <description>Watt</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exercise time (minutes), anerobic threshold.</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Heart Failure.</condition>
  <arm_group>
    <arm_group_label>CF-LVAD pumpspeed.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Incremental pump speed of CF-LVAD.</intervention_name>
    <description>Peak oxygen consumption with fixed versus incremental pump speed.</description>
    <arm_group_label>CF-LVAD pumpspeed.</arm_group_label>
    <other_name>HeartMate II.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HeartMate II patients who underwent surgery and follow-up at The Heart Centre of&#xD;
             Rigshospitalet.&#xD;
&#xD;
          -  Heart failure in stable phase without the need for intravenous inotropic therapy.&#xD;
&#xD;
          -  Ischemic and non-ischemic cardiomyopathy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe aortic insufficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.</name>
      <address>
        <city>Copenhagen.</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 10, 2014</last_update_submitted>
  <last_update_submitted_qc>February 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2014</last_update_posted>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT01698398
org study id: H-1-2012-092
nct id: NCT01698398
lead sponsor: 
The purpose of the study is to examine the relationship between working capacity (peak oxygen
      consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in
      heart failure patients. The hypothesis is that it is possible to increase peak oxygen
      consumption by incrementally increasing CF-LVAD pumpspeed during exercise.

      The study population will consist of severe heart failure patients with CF-LVADs treated at
      The Heart Centre of Copenhagen University Hospital Rigshospitalet.
allocation: Randomized
masking: Double (Participant, Investigator)
measure: Peak oxygen consumption.
time frame: Day 1
description: ml oxygen/minute/kg
measure: Working capacity.
time frame: Day 1
description: Watt
measure: Exercise time (minutes), anerobic threshold.
time frame: Day 1
arm group label: CF-LVAD pumpspeed.
arm group type: Experimental
description: Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
intervention type: Device
intervention name: Incremental pump speed of CF-LVAD.
description: Peak oxygen consumption with fixed versus incremental pump speed.
arm group label: CF-LVAD pumpspeed.
other name: HeartMate II.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Denmark
mesh term: Heart Failure