<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/NCT04493346</url>
  </required_header>
  <id_info>
    <org_study_id>018-164</org_study_id>
    <nct_id>NCT04493346</nct_id>
  </id_info>
  <brief_title>Shear Wave Elastography</brief_title>
  <official_title>Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</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>
      In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is&#xD;
      a serious complication post-surgery, associated with worsened outcomes including mortality.&#xD;
      However, predictors of decompensation after LVAD are not well established. Liver dysfunction&#xD;
      pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay&#xD;
      between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS)&#xD;
      is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis;&#xD;
      cirrhosis).&#xD;
&#xD;
      Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity&#xD;
      and mortality in patients undergoing LVAD implantation and yields increased need for advanced&#xD;
      postoperative HF therapies including the use of right ventricular assist devices (RVAD) for&#xD;
      the management of RHF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRESTUDY ASSESSMENTS Note: Assessments that are part of the standard of care and obtained&#xD;
      within 3-4 weeks of prestudy assessment visit, are acceptable as part of the screening tests.&#xD;
      Results of such tests will be acceptable even if obtained prior to the execution of the&#xD;
      Informed Consent.&#xD;
&#xD;
      Prior to entry into the study, the following assessments will be performed to determine if&#xD;
      patient is eligible to continue in the study as per section 4.2 and 4.3 describing the&#xD;
      inclusion and exclusion criteria for the study.&#xD;
&#xD;
        1. A signed Patient Informed Consent Form must be obtained.&#xD;
&#xD;
        2. A signed Patient Authorization Form (HIPAA) must be obtained.&#xD;
&#xD;
        3. It has been confirmed that the patient meets all inclusion criteria and none of the&#xD;
           exclusion criteria.&#xD;
&#xD;
        4. Assessment of concomitant medications must be obtained within 4 weeks prior to&#xD;
           registration.&#xD;
&#xD;
      ASSESSMENTS DURING STUDY&#xD;
&#xD;
      The following evaluations will be performed during the study:&#xD;
&#xD;
      1. An assessment of liver stiffness will be performed by shear wave elastography using a&#xD;
      Supersonic Imagine Aixplorer ShearWave™ ultrasound machine. Liver stiffness assessment will&#xD;
      be performed at a baseline visit (i.e., before LVAD placement for those undergoing LVAD&#xD;
      therapy), and if feasible at 1 month and 6 months post-therapy (for those undergoing advanced&#xD;
      therapy [i.e., LVAD or transplant]) or at 1 month and 6 months post-baseline (for those not&#xD;
      undergoing advanced therapy.) FOLLOW UP ASSESSMENTS The duration of patient participation in&#xD;
      the study will be a total of 12 months, which is counted from LVAD placement (or from&#xD;
      baseline, for those not undergoing LVAD therapy). Follow-ups will be performed at 1 month, 6&#xD;
      months, and 12 months, during which the following information will be documented on the CRF.&#xD;
&#xD;
      Note: Patients who die or withdraw consent are considered off study and no further&#xD;
      information will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2018</start_date>
  <completion_date type="Actual">April 11, 2022</completion_date>
  <primary_completion_date type="Actual">April 11, 2022</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>Liver stiffness (LS) measurements with development of post-LVAD RHF.</measure>
    <time_frame>24 months</time_frame>
    <description>An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 day in-hospital mortality rate</measure>
    <time_frame>30 days</time_frame>
    <description>We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1 year mortality rate</measure>
    <time_frame>1 year</time_frame>
    <description>We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate.</description>
  </secondary_outcome>
  <enrollment type="Actual">14</enrollment>
  <condition>Heart Failure</condition>
  <condition>Transplant; Failure, Heart</condition>
  <condition>Decompensated Heart Failure</condition>
  <condition>Fibrosis, Liver</condition>
  <condition>Cirrhosis, Liver</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Potential study participants are all adult patients in consideration for advanced HF&#xD;
        therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male patients ≥18 years of age.&#xD;
&#xD;
          -  Patient must be diagnosed with HF.&#xD;
&#xD;
          -  Patient must be referred for an evaluation for advanced HF therapy (i.e., LVAD or&#xD;
             heart transplantation).&#xD;
&#xD;
          -  Patient must be accessible for treatment and follow-up.&#xD;
&#xD;
          -  Outpatients only&#xD;
&#xD;
          -  All patients must be able to understand the investigational nature of the study and&#xD;
             give written informed consent prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe obesity (body mass index [BMI] &gt;35 kg/m2) or severe abdominal obesity&#xD;
&#xD;
          -  History of chronic or acute liver disease.&#xD;
&#xD;
          -  Positive test for hepatitis C antibody or hepatitis B surface antigen reactivity&#xD;
&#xD;
          -  History of intravenous drug or heavy alcohol use&#xD;
&#xD;
          -  Patients with ultrasound data showing liver surface nodularity as a surrogate for&#xD;
             advanced fibrosis.&#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>Amarinder Bindra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BSWHRI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Health research institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</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>Liver Cirrhosis</mesh_term>
    <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/NCT04493346
org study id: 018-164
nct id: NCT04493346
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is
      a serious complication post-surgery, associated with worsened outcomes including mortality.
      However, predictors of decompensation after LVAD are not well established. Liver dysfunction
      pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay
      between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS)
      is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis;
      cirrhosis).

      Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity
      and mortality in patients undergoing LVAD implantation and yields increased need for advanced
      postoperative HF therapies including the use of right ventricular assist devices (RVAD) for
      the management of RHF.
PRESTUDY ASSESSMENTS Note: Assessments that are part of the standard of care and obtained
      within 3-4 weeks of prestudy assessment visit, are acceptable as part of the screening tests.
      Results of such tests will be acceptable even if obtained prior to the execution of the
      Informed Consent.

      Prior to entry into the study, the following assessments will be performed to determine if
      patient is eligible to continue in the study as per section 4.2 and 4.3 describing the
      inclusion and exclusion criteria for the study.

        1. A signed Patient Informed Consent Form must be obtained.

        2. A signed Patient Authorization Form (HIPAA) must be obtained.

        3. It has been confirmed that the patient meets all inclusion criteria and none of the
           exclusion criteria.

        4. Assessment of concomitant medications must be obtained within 4 weeks prior to
           registration.

      ASSESSMENTS DURING STUDY

      The following evaluations will be performed during the study:

      1. An assessment of liver stiffness will be performed by shear wave elastography using a
      Supersonic Imagine Aixplorer ShearWave™ ultrasound machine. Liver stiffness assessment will
      be performed at a baseline visit (i.e., before LVAD placement for those undergoing LVAD
      therapy), and if feasible at 1 month and 6 months post-therapy (for those undergoing advanced
      therapy [i.e., LVAD or transplant]) or at 1 month and 6 months post-baseline (for those not
      undergoing advanced therapy.) FOLLOW UP ASSESSMENTS The duration of patient participation in
      the study will be a total of 12 months, which is counted from LVAD placement (or from
      baseline, for those not undergoing LVAD therapy). Follow-ups will be performed at 1 month, 6
      months, and 12 months, during which the following information will be documented on the CRF.

      Note: Patients who die or withdraw consent are considered off study and no further
      information will be collected.
observational model: Cohort
time perspective: Prospective
measure: Liver stiffness (LS) measurements with development of post-LVAD RHF.
time frame: 24 months
description: An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine.
measure: 30 day in-hospital mortality rate
time frame: 30 days
description: We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate.
measure: 1 year mortality rate
time frame: 1 year
description: We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amarinder Bindra, MD
role: Principal Investigator
affiliation: BSWHRI
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Heart Failure