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Growth Hormone Dynamics and Cardiac Steatosis in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826160
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

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.

Condition or disease
Human Immunodeficiency Virus Lipodystrophy Cardiac Disease

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hormones

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



Primary Outcome Measures :
  1. Intramyocardial lipid content [ Time Frame: 6 months ]
    Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)


Secondary Outcome Measures :
  1. Circumferential diastolic strain rate [ Time Frame: 6 months ]
    Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)


Biospecimen Retention:   Samples Without DNA
blood samples for subsequent processing


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
HIV patients, age 40-70 years old, with abdominal fat accumulation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826160


Contacts
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Contact: Lindsay T Fourman, MD 617-643-4590 lfourman@partners.org
Contact: Steven Grinspoon, MD 617-724-9109 sgrinspoon@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven Grinspoon, MD    617-724-9109    sgrinspoon@mgh.harvard.edu   
Principal Investigator: Steven Grinspoon, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
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Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03826160    
Other Study ID Numbers: 2018P001792
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Heart Diseases
Lipodystrophy
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases