<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/NCT03021239</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-1733</org_study_id>
    <nct_id>NCT03021239</nct_id>
  </id_info>
  <brief_title>Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life</brief_title>
  <acronym>Ramp-it-Up</acronym>
  <official_title>Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp&#xD;
      Tests to determine which method of testing provides better information for adjusting pump&#xD;
      speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better&#xD;
      adjustments may provide better quality of life, exercise tolerance and reduced unwanted&#xD;
      cardiac events over a 6-month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best&#xD;
      pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that&#xD;
      help guide medical treatment. The testing uses echocardiography (&quot;echo&quot;, ultrasound images of&#xD;
      the heart) to create heart images and make measurements while gradually increasing the Left&#xD;
      Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased,&#xD;
      images and measurements are taken. This is called a ramp test.&#xD;
&#xD;
      The ramp testing may also be performed during a right heart catheterization procedure. In a&#xD;
      catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or&#xD;
      artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging.&#xD;
      Doctors normally perform this procedure to measure the pressure and blood flow in the heart&#xD;
      (otherwise called hemodynamic measurements). If the ramp testing is performed during this&#xD;
      procedure, then the doctors have additional measurements to consider before choosing a final&#xD;
      speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.&#xD;
&#xD;
      All of the procedures in this study are considered standard of care. The research part is&#xD;
      randomly assigning the subject to one of the two methods of testing in this study. Subjects&#xD;
      have a 50/50 chance of being in either testing group.&#xD;
&#xD;
      Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)&#xD;
&#xD;
      The following will be performed:&#xD;
&#xD;
        -  Subjects will be asked to sign this consent form.&#xD;
&#xD;
        -  Physical exam with an assessment of heart failure symptoms, and medical history will be&#xD;
           recorded&#xD;
&#xD;
        -  Routine blood tests (about 1 tablespoon will be drawn)&#xD;
&#xD;
        -  Subjects will be randomly assigned to one of the two testing groups. If there is time,&#xD;
           the ramp test can be performed at this visit, but usually it will be scheduled to occur&#xD;
           a different day in about 1 to 4 weeks.&#xD;
&#xD;
        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If&#xD;
           needed, this can be completed the day of the ramp test.&#xD;
&#xD;
        -  Subjects will be asked to complete a questionnaire about their current quality of life.&#xD;
           This will take about 10 minutes. If needed, this can be completed the day of the ramp&#xD;
           test.&#xD;
&#xD;
      Ramp Testing Groups:&#xD;
&#xD;
        1. Echo Guided Testing - This testing uses echocardiography to create images of the heart&#xD;
           and make measurements while gradually increasing the heart pump speed. The final pump&#xD;
           speed and medical treatment are determined using the echo measurements. This will take&#xD;
           about 45 minutes.&#xD;
&#xD;
           OR&#xD;
&#xD;
        2. Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart&#xD;
           catheterization procedure which provides hemodynamic measurements (pressure and blood&#xD;
           flow) in addition to the echocardiography measurements. With this method, more echo&#xD;
           images and measurements are taken. The final pump speed and medical treatment&#xD;
           adjustments are made using the hemodynamic measurements as well as the information from&#xD;
           the echo. This test will take about 1 hour and 45 minutes.&#xD;
&#xD;
      6 Months after Baseline Visit&#xD;
&#xD;
      The following will be performed:&#xD;
&#xD;
        -  Physical exam with an assessment of heart failure symptoms, and medical history will be&#xD;
           recorded&#xD;
&#xD;
        -  Routine blood tests (about 1 tablespoon will be drawn)&#xD;
&#xD;
        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.&#xD;
&#xD;
        -  Subjects will be asked to complete a questionnaire about their current quality of life.&#xD;
           This will take about 10 minutes.&#xD;
&#xD;
        -  All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline&#xD;
           visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</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>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests</measure>
    <time_frame>6 Months</time_frame>
    <description>6 Walk Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Failure Readmission</measure>
    <time_frame>6 Months</time_frame>
    <description>Composite end-point of heart failure readmission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>6 Months</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>New York Heart Association (NYHA) Class</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Continous Flow Left Ventricular Device</condition>
  <arm_group>
    <arm_group_label>1) Echo Guided Testing -</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2) Hemodynamic-Echo Ramp Testing -</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echo Guided Testing</intervention_name>
    <arm_group_label>2) Hemodynamic-Echo Ramp Testing -</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hemodynamic-Echo Ramp Testing -</intervention_name>
    <arm_group_label>1) Echo Guided Testing -</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient older than 18 years&#xD;
&#xD;
          2. Newly implanted HVAD&#xD;
&#xD;
          3. HVAD support anticipated for at least 6 months&#xD;
&#xD;
          4. Patient is ambulatory and discharged from hospital without inotropes&#xD;
&#xD;
          5. Patient is between 1 and 3 months post implant&#xD;
&#xD;
          6. Patient has not had a right heart catheterization since discharged from HVAD&#xD;
             implantation hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The current HVAD is a replacement device&#xD;
&#xD;
          2. Patients currently has Right Ventricle (RV) failure requiring home inotropes&#xD;
&#xD;
          3. Inability to preformed right heart cath&#xD;
&#xD;
          4. Inadequate echocardiographic windows&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington School of Medicine</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ramp Test</keyword>
  <keyword>Continuous Flow -Left Ventricular Assist Device (CF-LVAD)</keyword>
  <keyword>LVAD Hemodynamics</keyword>
  <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/NCT03021239
org study id: IRB15-1733
nct id: NCT03021239
lead sponsor: 
has dmc: No
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp
      Tests to determine which method of testing provides better information for adjusting pump
      speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better
      adjustments may provide better quality of life, exercise tolerance and reduced unwanted
      cardiac events over a 6-month period.
All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best
      pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that
      help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of
      the heart) to create heart images and make measurements while gradually increasing the Left
      Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased,
      images and measurements are taken. This is called a ramp test.

      The ramp testing may also be performed during a right heart catheterization procedure. In a
      catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or
      artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging.
      Doctors normally perform this procedure to measure the pressure and blood flow in the heart
      (otherwise called hemodynamic measurements). If the ramp testing is performed during this
      procedure, then the doctors have additional measurements to consider before choosing a final
      speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.

      All of the procedures in this study are considered standard of care. The research part is
      randomly assigning the subject to one of the two methods of testing in this study. Subjects
      have a 50/50 chance of being in either testing group.

      Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)

      The following will be performed:

        -  Subjects will be asked to sign this consent form.

        -  Physical exam with an assessment of heart failure symptoms, and medical history will be
           recorded

        -  Routine blood tests (about 1 tablespoon will be drawn)

        -  Subjects will be randomly assigned to one of the two testing groups. If there is time,
           the ramp test can be performed at this visit, but usually it will be scheduled to occur
           a different day in about 1 to 4 weeks.

        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If
           needed, this can be completed the day of the ramp test.

        -  Subjects will be asked to complete a questionnaire about their current quality of life.
           This will take about 10 minutes. If needed, this can be completed the day of the ramp
           test.

      Ramp Testing Groups:

        1. Echo Guided Testing - This testing uses echocardiography to create images of the heart
           and make measurements while gradually increasing the heart pump speed. The final pump
           speed and medical treatment are determined using the echo measurements. This will take
           about 45 minutes.

           OR

        2. Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart
           catheterization procedure which provides hemodynamic measurements (pressure and blood
           flow) in addition to the echocardiography measurements. With this method, more echo
           images and measurements are taken. The final pump speed and medical treatment
           adjustments are made using the hemodynamic measurements as well as the information from
           the echo. This test will take about 1 hour and 45 minutes.

      6 Months after Baseline Visit

      The following will be performed:

        -  Physical exam with an assessment of heart failure symptoms, and medical history will be
           recorded

        -  Routine blood tests (about 1 tablespoon will be drawn)

        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.

        -  Subjects will be asked to complete a questionnaire about their current quality of life.
           This will take about 10 minutes.

        -  All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline
           visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
time frame: 6 Months
description: 6 Walk Test
measure: Heart Failure Readmission
time frame: 6 Months
description: Composite end-point of heart failure readmission.
measure: Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 6 Months
description: Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.
measure: New York Heart Association (NYHA) Class
time frame: 6 Months
arm group label: 1) Echo Guided Testing -
arm group type: Active Comparator
description: This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes.
arm group label: 2) Hemodynamic-Echo Ramp Testing -
arm group type: Active Comparator
description: This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.
intervention type: Procedure
intervention name: Echo Guided Testing
arm group label: 2) Hemodynamic-Echo Ramp Testing -
intervention type: Procedure
intervention name: Hemodynamic-Echo Ramp Testing -
arm group label: 1) Echo Guided Testing -
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No