Growth Hormone Dynamics and Cardiac Steatosis in HIV

Overview

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.

Full Title of Study: “Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 19, 2022

Arms, Groups and Cohorts

  • Tesamorelin
    • Individuals who plan to initiate tesamorelin clinically
  • No Treatment
    • Individuals who decline to initiate tesamorelin despite a clinical indication

Clinical Trial Outcome Measures

Primary Measures

  • Intramyocardial lipid content
    • Time Frame: 6 months
    • Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

Secondary Measures

  • Circumferential diastolic strain rate
    • Time Frame: 6 months
    • Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven K. Grinspoon, MD, Professor of Medicine – Massachusetts General Hospital
  • Overall Official(s)
    • Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.