Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Steven Grinspoon, MD
617-724-9109
sgrinspoon@mgh.harvard.edu

More Details

NCT ID
NCT03826160
Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Lindsay T Fourman, MD
617-643-4590
lfourman@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.