NCT03826160|Completed
Growth Hormone Dynamics and Cardiac Steatosis in HIV
Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
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Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
Sponsor study identifier
observational
23
1 country
1
Study Start
January 30, 2019
Actual (reported)Primary Completion
April 19, 2022
Actual (reported)Study Completion
April 19, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 19, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2019
Actual (reported)January 30, 2019
Actual (reported)February 1, 2019
Actual (reported)April 19, 2022
Actual (reported)April 19, 2022
Actual (reported)Intramyocardial lipid content
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
6 months
Circumferential diastolic strain rate
6 months
Individuals who plan to initiate tesamorelin clinically
Individuals who decline to initiate tesamorelin despite a clinical indication
HIV patients, age 40-70 years old, with abdominal fat accumulation
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
blood samples for subsequent processing
Steven Grinspoon, MD
Massachusetts General Hospital
23 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2019
First Posted
February 1, 2019
Study Start
January 30, 2019
Actual (reported)Tesamorelin Effects on Liver Fat and Histology in HIV
Contact the study team to confirm eligibility.
Primary Completion
April 19, 2022
Actual (reported)Study Completion
April 19, 2022
Actual (reported)Last Updated
July 19, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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