Growth Hormone Dynamics and Cardiac Steatosis in HIV

NCTNCT03826160Other id2018P001792

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 23 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Not stated
Countries: 1 country
United States
Start: 30 Jan 2019
Primary completion: 19 Apr 2022
Completion: 19 Apr 2022
First posted: 1 Feb 2019
Last update posted: 19 Jul 2022
Conditions: Human Immunodeficiency Virus · Lipodystrophy · Cardiac Disease

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020202120222023

Ph –
Growth Hormone Dynamics and Cardiac Steatosis in HIV
NCT03826160
30 Jan 2019 to 19 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms2

Other
Tesamorelin
Individuals who plan to initiate tesamorelin clinically
Other
No Treatment
Individuals who decline to initiate tesamorelin despite a clinical indication

Primary outcomes1

Outcomes the sponsor listed as primary.

Intramyocardial lipid content
Time frame · 6 months
Registry description
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

Secondary outcomes(1)

Circumferential diastolic strain rate
Time frame · 6 months
Registry description
Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 40 Years up to 70 Years
Healthy volunteers: Not stated

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.