Growth Hormone Dynamics and Cardiac Steatosis in HIV

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826160
• Other study ID #: 2018P001792
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: April 19, 2022

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiac Disease
• Heart Diseases
• HIV Infections
• Human Immunodeficiency Virus
• Lipodystrophy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intramyocardial lipid content	Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)	6 months
Secondary	Circumferential diastolic strain rate	Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)	6 months