Boston, Massachusetts 02114


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, they 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. They hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. They also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.


Criteria:

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


NCT ID:

NCT03826160


Primary Contact:

Principal Investigator
Steven Grinspoon, MD
Massachusetts General Hospital

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


Backup Contact:

Email: sgrinspoon@mgh.harvard.edu
Steven Grinspoon, MD
Phone: 617-724-9109


Location Contact:

Boston, Massachusetts 02114
United States

Steven Grinspoon, MD
Phone: 617-724-9109
Email: sgrinspoon@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.