<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/NCT03232736</url>
  </required_header>
  <id_info>
    <org_study_id>17-1042</org_study_id>
    <nct_id>NCT03232736</nct_id>
  </id_info>
  <brief_title>InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's</brief_title>
  <acronym>ROBIN</acronym>
  <official_title>Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary reason the investigators are doing this study are to understand how the right&#xD;
      side of the heart functions in heart failure patients with left ventricular assist devices&#xD;
      (LVADs, or &quot;mechanical hearts&quot;). Second, the investigators are interested in understanding&#xD;
      how different pacemaker settings influence function of the heart at rest and activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy individuals, as well as patients with advanced heart failure supported by LVADs,&#xD;
      completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided&#xD;
      heart function at rest and with exercise during invasive cardiopulmonary exercise testing on&#xD;
      upright cycle ergometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Vo2</measure>
    <time_frame>20 minutes</time_frame>
    <description>peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Output</measure>
    <time_frame>20 minutes</time_frame>
    <description>cardiac output measured during invasive cardiopulmonary exercise testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>20 minutes</time_frame>
    <description>mean arterial pressure during exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Exchange Ratio</measure>
    <time_frame>20 minutes</time_frame>
    <description>Respiratory exchange ratio derived from indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minute Ventilation</measure>
    <time_frame>20 minutes</time_frame>
    <description>Minute ventilation during cardiopulmonary exercise testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tau</measure>
    <time_frame>20 minutes</time_frame>
    <description>unit of measure of diastolic function during exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Work</measure>
    <time_frame>20 minutes</time_frame>
    <description>stroke work during exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EES/EA</measure>
    <time_frame>20 minutes</time_frame>
    <description>ventricular arterial coupling during exercise</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Heart Diseases</condition>
  <condition>Left Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LVAD Group</arm_group_label>
    <description>Individuals with history of advanced heart failure who are supported by left ventricular assist devices</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        15 patients with advanced HF who have already undergone CF-LVAD implantation.&#xD;
&#xD;
        10 healthy individuals will serve as a control group to define normal RV function during&#xD;
        exercise.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        15 patients with advanced heart failure (HF) who have already undergone implantation of a&#xD;
        continuous-flow left ventricular assist device (CF-LVAD) implantation.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Have already received CF-LVADs and are clinically stable,&#xD;
&#xD;
          2. Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD&#xD;
             implantation;&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Individuals with clinical right ventricular (RV) failure under resting conditions,&#xD;
             defined as moderate-severely reduced RV systolic function on echocardiography, or&#xD;
&#xD;
          2. Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+&#xD;
             [significant] peripheral edema);&#xD;
&#xD;
          3. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral&#xD;
             vascular disease, pulmonary disease); and&#xD;
&#xD;
        10 healthy individuals will serve as a control group to define normal RV function during&#xD;
        exercise.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        1) Persons without a past medical history of cardiovascular disease or related disease such&#xD;
        as:&#xD;
&#xD;
          1. hypertension,&#xD;
&#xD;
          2. diabetes,&#xD;
&#xD;
          3. peripheral vascular disease,&#xD;
&#xD;
          4. arrhythmias,&#xD;
&#xD;
        f. are not taking any cardiac-related medications (e.g. antihypertensive medications).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Individuals requiring systemic anticoagulation with vitamin-K antagonists or&#xD;
             new/direct oral anticoagulants (&quot;NOAC&quot;/&quot;DOAC&quot;);&#xD;
&#xD;
          2. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral&#xD;
             vascular disease).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Cornwell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cornwell WK, Tran T, Cerbin L, Coe G, Muralidhar A, Hunter K, Altman N, Ambardekar AV, Tompkins C, Zipse M, Schulte M, O'Gean K, Ostertag M, Hoffman J, Pal JD, Lawley JS, Levine BD, Wolfel E, Kohrt WM, Buttrick P. New insights into resting and exertional right ventricular performance in the healthy heart through real-time pressure-volume analysis. J Physiol. 2020 Jul;598(13):2575-2587. doi: 10.1113/JP279759. Epub 2020 May 18.</citation>
    <PMID>32347547</PMID>
  </reference>
  <reference>
    <citation>Tran T, Muralidhar A, Hunter K, Buchanan C, Coe G, Hieda M, Tompkins C, Zipse M, Spotts MJ, Laing SG, Fosmark K, Hoffman J, Ambardekar AV, Wolfel EE, Lawley J, Levine B, Kohrt WM, Pal J, Cornwell WK 3rd. Right ventricular function and cardiopulmonary performance among patients with heart failure supported by durable mechanical circulatory support devices. J Heart Lung Transplant. 2021 Feb;40(2):128-137. doi: 10.1016/j.healun.2020.11.009. Epub 2020 Nov 22.</citation>
    <PMID>33281029</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>June 18, 2021</results_first_submitted>
  <results_first_submitted_qc>August 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 27, 2021</results_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03232736/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03232736/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Control</title>
          <description>healthy individuals free of cardiovascular disease and not on any cardiac-related medications, age &gt; 18years.</description>
        </group>
        <group group_id="P2">
          <title>LVAD Group w/Pacemaker</title>
          <description>Pacemaker adjustments will be made to this group in blinded manner.&#xD;
Pacemaker adjustments: LVAD subjects with CRT device will have leads turned both on and off in blinded manner&#xD;
CRT: CRT device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Healthy individuals are those who are free of cardiovascular disease and not on any medications to treat a cardiovascular disease. Patients with LVADs are those with a history of advanced heart failure who are supported by an LVAD</population>
      <group_list>
        <group group_id="B1">
          <title>Healthy Control</title>
          <description>Healthy controls free of heart disease and not on any medications. Age 18+ years</description>
        </group>
        <group group_id="B2">
          <title>LVAD Group</title>
          <description>Heart failure patients supported by LVAD</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" spread="12"/>
                    <measurement group_id="B2" value="61" spread="9"/>
                    <measurement group_id="B3" value="52" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Vo2</title>
        <description>peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Vo2</title>
          <description>peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing</description>
          <units>ml/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="10.4"/>
                    <measurement group_id="O2" value="12.5" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cardiac Output</title>
        <description>cardiac output measured during invasive cardiopulmonary exercise testing.</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people without cardiac disease</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patient supported by lvads.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Output</title>
          <description>cardiac output measured during invasive cardiopulmonary exercise testing.</description>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="7.3"/>
                    <measurement group_id="O2" value="9.1" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Pressure</title>
        <description>mean arterial pressure during exercise</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group</title>
            <description>Individuals with history of advanced heart failure who are supported by left ventricular assist devices</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>mean arterial pressure during exercise</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119" spread="7"/>
                    <measurement group_id="O2" value="91" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Exchange Ratio</title>
        <description>Respiratory exchange ratio derived from indirect calorimetry</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Exchange Ratio</title>
          <description>Respiratory exchange ratio derived from indirect calorimetry</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.08"/>
                    <measurement group_id="O2" value="0.03" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minute Ventilation</title>
        <description>Minute ventilation during cardiopulmonary exercise testing</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>Minute Ventilation</title>
          <description>Minute ventilation during cardiopulmonary exercise testing</description>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102" spread="40"/>
                    <measurement group_id="O2" value="56" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tau</title>
        <description>unit of measure of diastolic function during exercise</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>Tau</title>
          <description>unit of measure of diastolic function during exercise</description>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="6"/>
                    <measurement group_id="O2" value="54" spread="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stroke Work</title>
        <description>stroke work during exercise</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Work</title>
          <description>stroke work during exercise</description>
          <units>mmHg*mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4999" spread="2342"/>
                    <measurement group_id="O2" value="2455" spread="783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EES/EA</title>
        <description>ventricular arterial coupling during exercise</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>healthy people free of heart disease.</description>
          </group>
          <group group_id="O2">
            <title>LVAD Group w/Pacemaker</title>
            <description>heart failure patients supported by an LVD.</description>
          </group>
        </group_list>
        <measure>
          <title>EES/EA</title>
          <description>ventricular arterial coupling during exercise</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.8"/>
                    <measurement group_id="O2" value="1.40" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Control</title>
          <description>healthy people free of heart disease.</description>
        </group>
        <group group_id="E2">
          <title>LVAD Group w/Pacemaker</title>
          <description>Heart failure patients supported by an LVAD.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>William Cornwell</name_or_title>
      <organization>University of Colorado Anschutz Medical Campus</organization>
      <phone>16142961686</phone>
      <email>william.cornwell@ucdenver.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03232736
org study id: 17-1042
nct id: NCT03232736
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary reason the investigators are doing this study are to understand how the right
      side of the heart functions in heart failure patients with left ventricular assist devices
      (LVADs, or "mechanical hearts"). Second, the investigators are interested in understanding
      how different pacemaker settings influence function of the heart at rest and activity.
Healthy individuals, as well as patients with advanced heart failure supported by LVADs,
      completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided
      heart function at rest and with exercise during invasive cardiopulmonary exercise testing on
      upright cycle ergometry.
observational model: Other
time perspective: Prospective
measure: Peak Vo2
time frame: 20 minutes
description: peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing
measure: Cardiac Output
time frame: 20 minutes
description: cardiac output measured during invasive cardiopulmonary exercise testing.
measure: Blood Pressure
time frame: 20 minutes
description: mean arterial pressure during exercise
measure: Respiratory Exchange Ratio
time frame: 20 minutes
description: Respiratory exchange ratio derived from indirect calorimetry
measure: Minute Ventilation
time frame: 20 minutes
description: Minute ventilation during cardiopulmonary exercise testing
measure: Tau
time frame: 20 minutes
description: unit of measure of diastolic function during exercise
measure: Stroke Work
time frame: 20 minutes
description: stroke work during exercise
measure: EES/EA
time frame: 20 minutes
description: ventricular arterial coupling during exercise
arm group label: Healthy Control
description: Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition
arm group label: LVAD Group
description: Individuals with history of advanced heart failure who are supported by left ventricular assist devices
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Cornwell, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Cornwell WK, Tran T, Cerbin L, Coe G, Muralidhar A, Hunter K, Altman N, Ambardekar AV, Tompkins C, Zipse M, Schulte M, O'Gean K, Ostertag M, Hoffman J, Pal JD, Lawley JS, Levine BD, Wolfel E, Kohrt WM, Buttrick P. New insights into resting and exertional right ventricular performance in the healthy heart through real-time pressure-volume analysis. J Physiol. 2020 Jul;598(13):2575-2587. doi: 10.1113/JP279759. Epub 2020 May 18.
PMID: 32347547
citation: Tran T, Muralidhar A, Hunter K, Buchanan C, Coe G, Hieda M, Tompkins C, Zipse M, Spotts MJ, Laing SG, Fosmark K, Hoffman J, Ambardekar AV, Wolfel EE, Lawley J, Levine B, Kohrt WM, Pal J, Cornwell WK 3rd. Right ventricular function and cardiopulmonary performance among patients with heart failure supported by durable mechanical circulatory support devices. J Heart Lung Transplant. 2021 Feb;40(2):128-137. doi: 10.1016/j.healun.2020.11.009. Epub 2020 Nov 22.
PMID: 33281029
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Left
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 