Brief Title
Growth Hormone Dynamics and Cardiac Steatosis in HIV
Official Title
Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
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.
Study Type
Observational
Primary Outcome
Intramyocardial lipid content
Secondary Outcome
Circumferential diastolic strain rate
Condition
Human Immunodeficiency Virus
Study Arms / Comparison Groups
Tesamorelin
Description: Individuals who plan to initiate tesamorelin clinically
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
30
Start Date
January 30, 2019
Completion Date
January 30, 2021
Primary Completion Date
January 30, 2021
Eligibility 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
Gender
All
Ages
40 Years - 70 Years
Contacts
Steven Grinspoon, MD, 617-643-4590, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03826160
Organization ID
2018P001792
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
Verification Date
August 2019