Growth Hormone Dynamics and Cardiac Steatosis in HIV

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Lipodystrophy
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Brief Title

Growth Hormone Dynamics and Cardiac Steatosis in HIV

Official Title

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

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.

Study Type

Observational

Primary Outcome

Intramyocardial lipid content

Secondary Outcome

 Circumferential diastolic strain rate

Condition

Human Immunodeficiency Virus

Study Arms / Comparison Groups

 Tesamorelin
Description:  Individuals who plan to initiate tesamorelin clinically

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

30

Start Date

January 30, 2019

Completion Date

January 30, 2021

Primary Completion Date

January 30, 2021

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

Gender

All

Ages

40 Years - 70 Years

Contacts

Steven Grinspoon, MD, 617-643-4590, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03826160

Organization ID

2018P001792

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Study Sponsor

Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital

Verification Date

August 2019