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Growth Hormone Dynamics and Cardiac Steatosis in HIV

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03826160
Collaborator
(none)
23
Enrollment
1
Location
38.6
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    23 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
    Actual Study Start Date :
    Jan 30, 2019
    Actual Primary Completion Date :
    Apr 19, 2022
    Actual Study Completion Date :
    Apr 19, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Tesamorelin

    Individuals who plan to initiate tesamorelin clinically
    No Treatment

    Individuals who decline to initiate tesamorelin despite a clinical indication

    Outcome Measures

    Primary Outcome Measures

    1. Intramyocardial lipid content [6 months]

      Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

    Secondary Outcome Measures

    1. Circumferential diastolic strain rate [6 months]

      Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Men and women, ages 40-70 years

    • Documented HIV infection on stable antiretroviral therapy for ≥ 3 months

    • Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women

    • Indication for tesamorelin per clinical judgment

    Exclusion Criteria:

    • CD4 < 100 cells/mm3 or HIV viral load > 400 copies/mL

    • Current active AIDS-defining illness

    • History or symptoms consistent with heart failure

    • Standard contraindications to MRI including severe allergy to gadolinium

    • Glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 within one month of MRI study

    • Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months

    • HbA1c > 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months

    • Change in statin therapy within the past 3 months

    • Chronic corticosteroid use except intermittent topic steroid creams or inhalers

    • Pregnancy or breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Steven Grinspoon, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03826160
    Other Study ID Numbers:
    • 2018P001792
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Heart Diseases
    Lipodystrophy

    Study Results

    No Results Posted as of Jul 19, 2022