<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/NCT02966899</url>
  </required_header>
  <id_info>
    <org_study_id>312231</org_study_id>
    <nct_id>NCT02966899</nct_id>
  </id_info>
  <brief_title>Reversal of Right Ventricular Steatosis in Pulmonary Hypertension</brief_title>
  <official_title>Reversal of Right Ventricular Steatosis in Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Providence VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Providence VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to elucidate the relationship between myocardial right ventricular&#xD;
      triglyceride content (steatosis) and right ventricular dysfunction in participants with&#xD;
      pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty&#xD;
      acid treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to treat 30 participants that are identified as having elevated&#xD;
      myocardial triglyceride content (defined as greater than 0.50%) on cardiac MRI with 4 grams&#xD;
      of omega-3 fatty acids daily for six months with a primary end point of reducing right&#xD;
      ventricular steatosis and a secondary endpoint of improving RV systolic function. The&#xD;
      investigators hypothesize that right ventricular steatosis by cardiac MRI will be associated&#xD;
      with the degree of right ventricular systolic function by cardiac MRI. In the subset of&#xD;
      participants with elevated baseline steatosis who are treated with a lipoprotective strategy,&#xD;
      the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce&#xD;
      myocardial steatosis and improve right ventricular systolic function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pulmonary; Hypertension</condition>
  <condition>Steatosis</condition>
  <condition>Right Ventricular Failure</condition>
  <arm_group>
    <arm_group_label>Omega-3 fatty acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 patients with pulmonary hypertension who are identified as having elevated myocardial triglyceride content by cardiac MRI will receive 4 grams/day of omega-3 fatty acids for six months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 fatty acids</intervention_name>
    <arm_group_label>Omega-3 fatty acids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men and women &gt; 30 years of age with a diagnosis of pulmonary hypertension&#xD;
             (defined as mean pulmonary arterial pressure ≥25 mmHg at rest on right heart&#xD;
             catheterization)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI (e.g., metallic hazards or allergy to gadolinium)&#xD;
&#xD;
          -  Renal dysfunction (eGFR &lt; 60 ml/min/1.73m2 as estimated by the Modified Diet in Renal&#xD;
             Disease formula)&#xD;
&#xD;
          -  High risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal&#xD;
             transplant)&#xD;
&#xD;
          -  Active pregnancy or breastfeeding (determined by urinary pregnancy test before CMR)&#xD;
&#xD;
          -  Weight &gt; 550 lb or waist diameter &gt; 70 cm (limits for our Siemens Verio CMR system)&#xD;
&#xD;
          -  Fish Allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Providence VA Medical Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siddique A Abbasi, MD</last_name>
      <phone>401-273-7100</phone>
      <phone_ext>2265</phone_ext>
      <email>siddique_abbasi@brown.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Providence VA Medical Center</investigator_affiliation>
    <investigator_full_name>Siddique Abbasi</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02966899
org study id: 312231
nct id: NCT02966899
lead sponsor: 
has dmc: No
The goal of this study is to elucidate the relationship between myocardial right ventricular
      triglyceride content (steatosis) and right ventricular dysfunction in participants with
      pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty
      acid treatment.
The investigators propose to treat 30 participants that are identified as having elevated
      myocardial triglyceride content (defined as greater than 0.50%) on cardiac MRI with 4 grams
      of omega-3 fatty acids daily for six months with a primary end point of reducing right
      ventricular steatosis and a secondary endpoint of improving RV systolic function. The
      investigators hypothesize that right ventricular steatosis by cardiac MRI will be associated
      with the degree of right ventricular systolic function by cardiac MRI. In the subset of
      participants with elevated baseline steatosis who are treated with a lipoprotective strategy,
      the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce
      myocardial steatosis and improve right ventricular systolic function.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
time frame: 6 months
measure: Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
time frame: 6 months
arm group label: Omega-3 fatty acids
arm group type: Experimental
description: 30 patients with pulmonary hypertension who are identified as having elevated myocardial triglyceride content by cardiac MRI will receive 4 grams/day of omega-3 fatty acids for six months.
intervention type: Dietary Supplement
intervention name: Omega-3 fatty acids
arm group label: Omega-3 fatty acids
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Providence VA Medical Center
investigator full name: Siddique Abbasi
investigator title: Assistant Professor of Medicine
mesh term: Fatty Liver
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: Undecided