Growth Hormone Dynamics and Cardiac Steatosis 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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiac Disease Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Infections Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Intramyocardial lipid content

Time frame: 6 months

Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

Secondary outcomes

Circumferential diastolic strain rate

Time frame: 6 months

Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Feb 1, 2019
Registry last updated: Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed