Intramyocardial lipid content
Time frame · 6 months
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
Growth Hormone Dynamics and Cardiac Steatosis in HIV
Status
Completed
Phase
Not applicable
Enrollment
23
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Feb 1, 2019
Study start
Jan 30, 2019
Primary completion
Apr 19, 2022
Study completion
Apr 19, 2022
Results posted
Not reported
Registry updated
Jul 19, 2022
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
Circumferential diastolic strain rate
Time frame · 6 months
Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- Not reported
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Tesamorelin.
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