<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/NCT03238755</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001999</org_study_id>
    <nct_id>NCT03238755</nct_id>
  </id_info>
  <brief_title>Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study</brief_title>
  <official_title>Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, investigators plan to test whether statins can preserve and/or improve&#xD;
      diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy.&#xD;
      Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic&#xD;
      dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo&#xD;
      cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial&#xD;
      steatosis prior to initiation of statin or placebo therapy and then two years after&#xD;
      initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk,&#xD;
      systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and&#xD;
      markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">April 23, 2024</completion_date>
  <primary_completion_date type="Actual">June 22, 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>Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic function on Cardiac MRI</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Myocardial Inflammation on Cardiac MRI</measure>
    <time_frame>Two Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intramyocardial fat on Cardiac MRI/MRS</measure>
    <time_frame>Two Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic function on Cardiac MRI</measure>
    <time_frame>Two Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visceral Adiposity on MRS</measure>
    <time_frame>Two Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch</measure>
    <time_frame>Two Years</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">129</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Statin group</arm_group_label>
    <description>HIV-infected individuals receiving statin therapy for the duration of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <description>HIV-infected individuals receiving placebo therapy for the duration of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac MRI/MRS</intervention_name>
    <description>whole blood, plasma, and serum</description>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Statin group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, plasma, and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        HIV-infected subjects on ART from the community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New enrollment in the REPRIEVE Trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of HFpEF or HFrEF, by subject report&#xD;
&#xD;
          -  standard contraindications to MRI procedure based on MRI Patient Procedure Screening&#xD;
             Form - including history of severe allergy to gadolinium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Medical Center-Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UTSW Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cape Town</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Tomas G. Neilan, MD</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Diastolic Dysfunction</keyword>
  <keyword>Myocardial fibrosis</keyword>
  <keyword>Statin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</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/NCT03238755
org study id: 2016P001999
nct id: NCT03238755
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
In this study, investigators plan to test whether statins can preserve and/or improve
      diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy.
      Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic
      dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo
      cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial
      steatosis prior to initiation of statin or placebo therapy and then two years after
      initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk,
      systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and
      markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS
      outcomes.
observational model: Cohort
time perspective: Prospective
measure: Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI
time frame: Two years
measure: Diastolic function on Cardiac MRI
time frame: Two years
measure: Myocardial Inflammation on Cardiac MRI
time frame: Two Years
measure: Intramyocardial fat on Cardiac MRI/MRS
time frame: Two Years
measure: Diastolic function on Cardiac MRI
time frame: Two Years
measure: Visceral Adiposity on MRS
time frame: Two Years
measure: Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch
time frame: Two Years
arm group label: Statin group
description: HIV-infected individuals receiving statin therapy for the duration of the study
arm group label: Placebo group
description: HIV-infected individuals receiving placebo therapy for the duration of the study
intervention type: Other
intervention name: Cardiac MRI/MRS
description: whole blood, plasma, and serum
arm group label: Placebo group
arm group label: Statin group
whole blood, plasma, and serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: South Africa
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Tomas G. Neilan, MD
investigator title: Physician
mesh term: HIV Infections