Growth Hormone Dynamics and Cardiac Steatosis in HIV

Study Overview
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Brief Summary
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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.

Official Title
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Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV

Conditions
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Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tesamorelin<br>Individuals who plan to initiate tesamorelin clinically | |
| No Treatment<br>Individuals who decline to initiate tesamorelin despite a clinical indication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramyocardial lipid content | Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumferential diastolic strain rate | Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI) | 6 months |