Growth Hormone Dynamics and Cardiac Steatosis in HIV

Completed

• Conditions: Cardiac Disease; Human Immunodeficiency Virus; Lipodystrophy

• Registration Number: NCT03826160
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-30
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States