Growth Hormone Dynamics and Cardiac Steatosis in HIV

NCT ID: NCT03826160

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2022-04-19

Brief 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.

Conditions

Human Immunodeficiency Virus; Lipodystrophy; Cardiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tesamorelin

Individuals who plan to initiate tesamorelin clinically

No interventions assigned to this group

No Treatment

Individuals who decline to initiate tesamorelin despite a clinical indication

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven K. Grinspoon, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Grinspoon, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P001792

Identifier Type: -

Identifier Source: org_study_id