Growth Hormone Dynamics and Cardiac Steatosis in HIV
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, HIV / AIDS, HIV / AIDS, HIV / AIDS, Endocrine, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 2/7/2019 |
| Start Date: | January 30, 2019 |
| End Date: | January 30, 2021 |
| Contact: | Lindsay T Fourman, MD |
| Email: | lfourman@partners.org |
| Phone: | 617-643-4590 |
Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Steven Grinspoon, MD
Phone: 617-724-9109
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