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

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus; Cardiac Disease; Lipodystrophy

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV patients, age 40-70 years old, with abdominal fat accumulation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Tesamorelin; Individuals who plan to initiate tesamorelin clinically
No Treatment; Individuals who decline to initiate tesamorelin despite a clinical indication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intramyocardial lipid content	Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circumferential diastolic strain rate	Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2019
• Primary Completion (ACTUAL): April 19, 2022
• Study Completion (ACTUAL): April 19, 2022

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases; Skin Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Slow Virus Diseases; Skin Diseases, Metabolic; Heart Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Lipodystrophy
• Other Study ID Numbers: 2018P001792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No