<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/NCT03826160</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001792</org_study_id>
    <nct_id>NCT03826160</nct_id>
  </id_info>
  <brief_title>Growth Hormone Dynamics and Cardiac Steatosis in HIV</brief_title>
  <official_title>Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac&#xD;
      mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of&#xD;
      cardiac steatosis is not well understood. The investigators have previously shown that&#xD;
      perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the&#xD;
      viscera and the liver. Moreover, the investigators have found that augmentation of endogenous&#xD;
      GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat.&#xD;
      In this longitudinal observational study, the investigators will examine patients with HIV&#xD;
      and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin&#xD;
      prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is&#xD;
      associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin&#xD;
      for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">April 19, 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>Intramyocardial lipid content</measure>
    <time_frame>6 months</time_frame>
    <description>Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Circumferential diastolic strain rate</measure>
    <time_frame>6 months</time_frame>
    <description>Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Lipodystrophy</condition>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>Tesamorelin</arm_group_label>
    <description>Individuals who plan to initiate tesamorelin clinically</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
    <description>Individuals who decline to initiate tesamorelin despite a clinical indication</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples for subsequent processing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        HIV patients, age 40-70 years old, with abdominal fat accumulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, ages 40-70 years&#xD;
&#xD;
          -  Documented HIV infection on stable antiretroviral therapy for ≥ 3 months&#xD;
&#xD;
          -  Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women&#xD;
&#xD;
          -  Indication for tesamorelin per clinical judgment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CD4 &lt; 100 cells/mm3 or HIV viral load &gt; 400 copies/mL&#xD;
&#xD;
          -  Current active AIDS-defining illness&#xD;
&#xD;
          -  History or symptoms consistent with heart failure&#xD;
&#xD;
          -  Standard contraindications to MRI including severe allergy to gadolinium&#xD;
&#xD;
          -  Glomerular filtration rate (eGFR) &lt; 45 mL/min/1.73 m2 within one month of MRI study&#xD;
&#xD;
          -  Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past&#xD;
             6 months&#xD;
&#xD;
          -  HbA1c &gt; 7%, chronic insulin use within the past 6 months, and/or change in&#xD;
             anti-diabetic agents within the past 3 months&#xD;
&#xD;
          -  Change in statin therapy within the past 3 months&#xD;
&#xD;
          -  Chronic corticosteroid use except intermittent topic steroid creams or inhalers&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Steven Grinspoon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Steven K. Grinspoon, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Lipodystrophy</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/NCT03826160
org study id: 2018P001792
nct id: NCT03826160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac
      mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of
      cardiac steatosis is not well understood. The investigators have previously shown that
      perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the
      viscera and the liver. Moreover, the investigators have found that augmentation of endogenous
      GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat.
      In this longitudinal observational study, the investigators will examine patients with HIV
      and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin
      prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is
      associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin
      for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac
      function.
observational model: Cohort
time perspective: Prospective
measure: Intramyocardial lipid content
time frame: 6 months
description: Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
measure: Circumferential diastolic strain rate
time frame: 6 months
description: Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)
arm group label: Tesamorelin
description: Individuals who plan to initiate tesamorelin clinically
arm group label: No Treatment
description: Individuals who decline to initiate tesamorelin despite a clinical indication
blood samples for subsequent processing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
last name: Steven Grinspoon, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Steven K. Grinspoon, MD
investigator title: Professor of Medicine
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Heart Diseases
mesh term: Lipodystrophy
sharing ipd: Undecided