<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/NCT03784963</url>
  </required_header>
  <id_info>
    <org_study_id>IRB18-0576</org_study_id>
    <nct_id>NCT03784963</nct_id>
  </id_info>
  <brief_title>Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD</brief_title>
  <official_title>Open-Label Prospective Randomized Control Trial to Investigate the Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With Continuous-Flow Left Ventricular Assist Device</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of high-dose fish oil in decreasing rates of&#xD;
      gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.&#xD;
      Half of the patients without history of bleeding will receive fish oil while the other half&#xD;
      will not. Half of the patients with history of bleeding will receive fish oil while the other&#xD;
      half will not. Markers of angiogenesis and inflammation, as well as changes in the microbiome&#xD;
      will be assessed in each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A potential mechanism of bleeding in patients with continuous-flow left ventricular assist&#xD;
      devices (CF-LVAD) is dysfunctional angiogenesis. Angiogenesis is a complicated process&#xD;
      controlled by several markers. Previous studies have shown that elevated Angiopoietin-2 and&#xD;
      TNF-alpha are associated with bleeding events in CF-LVAD patients.&#xD;
&#xD;
      Fish oil has anti-inflammatory and potentially anti-angiogenic properties. A retrospective&#xD;
      study of CF-LVAD patients on high-dose fish oil showed a marked decrease in gastrointestinal&#xD;
      bleeding rates in these patients. Additionally, these patients had lower levels of&#xD;
      circulating Angiopoietin-2. Fish oil is known to have an effect on the microbiome, and the&#xD;
      aforementioned effects may be seen in changes of the microbiota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF</measure>
    <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
    <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include Angiopoietin-1 (ng/mL), Angiopoietin-2 (ng/mL), and VEGF (ng/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Markers of Angiogenesis - TNF-alpha</measure>
    <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
    <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Markers of Inflammation - C-Reactive Protein</measure>
    <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
    <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of Gastrointestinal Bleeding</measure>
    <time_frame>Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.</time_frame>
    <description>Rates of Gastrointestinal Bleeding will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Microbiome</measure>
    <time_frame>The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
    <description>The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Heart Failure</condition>
  <condition>Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>Primary Prevention Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Prevention Non-Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary Prevention Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary Prevention Non-Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega 3 fatty acids</intervention_name>
    <description>Patients will receive 4 grams fish oil once daily</description>
    <arm_group_label>Primary Prevention Intervention</arm_group_label>
    <arm_group_label>Secondary Prevention Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Standard of care</description>
    <arm_group_label>Primary Prevention Non-Intervention</arm_group_label>
    <arm_group_label>Secondary Prevention Non-Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has signed consent&#xD;
&#xD;
          2. Age &gt; 18 years&#xD;
&#xD;
          3. Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial&#xD;
             issues that might impair compliance with the study.&#xD;
&#xD;
          2. Patients already taking fish oil.&#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>Ann Nguyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <results_first_submitted>May 27, 2021</results_first_submitted>
  <results_first_submitted_qc>June 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2021</results_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Angiogenesis</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</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>June 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03784963/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Primary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="P2">
          <title>Primary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
        <group group_id="P3">
          <title>Secondary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="P4">
          <title>Secondary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
      <group_list>
        <group group_id="B1">
          <title>Primary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="B2">
          <title>Primary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
        <group group_id="B3">
          <title>Secondary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="B4">
          <title>Secondary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
        <group group_id="B5">
          <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="12"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="0"/>
            <count group_id="B5" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" lower_limit="49" upper_limit="59.5"/>
                    <measurement group_id="B2" value="53.5" lower_limit="37" upper_limit="73"/>
                    <measurement group_id="B3" value="76" lower_limit="76" upper_limit="76"/>
                    <measurement group_id="B5" value="55" lower_limit="49" upper_limit="59.5"/>
                  </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="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="9"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ischemic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dilated Cardiomyopathy</title>
          <description>Dilated cardiomyopathy is etiology of heart failure and a disease of the heart muscle of the left ventricle, specifically in its ability to dilate.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Dilated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Dilated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus (DM)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Diabetes Mellitus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Diabetes Mellitus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension (HTN)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hypertension</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Hypertension</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cerebrovascular accident and Stroke (CVA)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Cerebrovascular accident and Stroke</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Cerebrovascular accident and Stroke</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Obstructive Sleep Apnea (OSA)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Obstructive Sleep Apnea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Obstructive Sleep Apnea</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Chronic Obstructive Pulmonary Disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Chronic Obstructive Pulmonary Disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-LVAD Implant New York Heart Association Class (NYHA)</title>
          <description>NYHA class determines the functional status of the patient. There are classes I-IV. Class I is no symptoms and IV is symptoms at rest.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)</title>
          <description>The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) identifies patients with advanced heart failure undergoing mechanical circulatory support (MCS) at risk of complications after MCS. The INTERMACS scale goes from 1-7, where INTERMACS 1 is &quot;crash and burn&quot; and 7 is stable at home with some symptoms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LVAD Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>HeartMate II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Heartware Ventricular Assisted Device (HVAD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Heart Mate III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF</title>
        <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include Angiopoietin-1 (ng/mL), Angiopoietin-2 (ng/mL), and VEGF (ng/mL).</description>
        <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
        <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O2">
            <title>Primary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
          <group group_id="O3">
            <title>Secondary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O4">
            <title>Secondary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF</title>
          <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include Angiopoietin-1 (ng/mL), Angiopoietin-2 (ng/mL), and VEGF (ng/mL).</description>
          <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Markers of Angiogenesis - TNF-alpha</title>
        <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).</description>
        <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
        <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O2">
            <title>Primary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
          <group group_id="O3">
            <title>Secondary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O4">
            <title>Secondary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Markers of Angiogenesis - TNF-alpha</title>
          <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).</description>
          <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Markers of Inflammation - C-Reactive Protein</title>
        <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).</description>
        <time_frame>Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
        <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O2">
            <title>Primary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
          <group group_id="O3">
            <title>Secondary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O4">
            <title>Secondary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Markers of Inflammation - C-Reactive Protein</title>
          <description>Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).</description>
          <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rates of Gastrointestinal Bleeding</title>
        <description>Rates of Gastrointestinal Bleeding will be assessed.</description>
        <time_frame>Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.</time_frame>
        <population>Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O2">
            <title>Primary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
          <group group_id="O3">
            <title>Secondary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O4">
            <title>Secondary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Gastrointestinal Bleeding</title>
          <description>Rates of Gastrointestinal Bleeding will be assessed.</description>
          <population>Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Microbiome</title>
        <description>The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.</description>
        <time_frame>The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.</time_frame>
        <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O2">
            <title>Primary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
          <group group_id="O3">
            <title>Secondary Prevention Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
          </group>
          <group group_id="O4">
            <title>Secondary Prevention Non-Intervention</title>
            <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Microbiome</title>
          <description>The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.</description>
          <population>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected within the first year of the study.</time_frame>
      <desc>Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.&#xD;
Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Primary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="E2">
          <title>Primary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
        <group group_id="E3">
          <title>Secondary Prevention Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.&#xD;
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily</description>
        </group>
        <group group_id="E4">
          <title>Secondary Prevention Non-Intervention</title>
          <description>In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.&#xD;
Placebo: Standard of care</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea and indigestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ann Nguyen, MD</name_or_title>
      <organization>The University of Chicago</organization>
      <phone>773-702-9396</phone>
      <email>anguyen3@medicine.bsd.uchicago.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/NCT03784963
org study id: IRB18-0576
nct id: NCT03784963
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study evaluates the efficacy of high-dose fish oil in decreasing rates of
      gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.
      Half of the patients without history of bleeding will receive fish oil while the other half
      will not. Half of the patients with history of bleeding will receive fish oil while the other
      half will not. Markers of angiogenesis and inflammation, as well as changes in the microbiome
      will be assessed in each group.
A potential mechanism of bleeding in patients with continuous-flow left ventricular assist
      devices (CF-LVAD) is dysfunctional angiogenesis. Angiogenesis is a complicated process
      controlled by several markers. Previous studies have shown that elevated Angiopoietin-2 and
      TNF-alpha are associated with bleeding events in CF-LVAD patients.

      Fish oil has anti-inflammatory and potentially anti-angiogenic properties. A retrospective
      study of CF-LVAD patients on high-dose fish oil showed a marked decrease in gastrointestinal
      bleeding rates in these patients. Additionally, these patients had lower levels of
      circulating Angiopoietin-2. Fish oil is known to have an effect on the microbiome, and the
      aforementioned effects may be seen in changes of the microbiota.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF
time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
description: Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include Angiopoietin-1 (ng/mL), Angiopoietin-2 (ng/mL), and VEGF (ng/mL).
measure: Change in Markers of Angiogenesis - TNF-alpha
time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
description: Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).
measure: Change in Markers of Inflammation - C-Reactive Protein
time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
description: Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).
measure: Rates of Gastrointestinal Bleeding
time frame: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.
description: Rates of Gastrointestinal Bleeding will be assessed.
measure: Changes in the Microbiome
time frame: The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
description: The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.
arm group label: Primary Prevention Intervention
arm group type: Experimental
description: In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.
arm group label: Primary Prevention Non-Intervention
arm group type: Placebo Comparator
description: In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.
arm group label: Secondary Prevention Intervention
arm group type: Experimental
description: In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.
arm group label: Secondary Prevention Non-Intervention
arm group type: Placebo Comparator
description: In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.
intervention type: Drug
intervention name: Omega 3 fatty acids
description: Patients will receive 4 grams fish oil once daily
arm group label: Primary Prevention Intervention
arm group label: Secondary Prevention Intervention
intervention type: Other
intervention name: Placebo
description: Standard of care
arm group label: Primary Prevention Non-Intervention
arm group label: Secondary Prevention Non-Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann Nguyen, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
point of contact: 