跳至主要内容
临床试验/NCT03826160
NCT03826160已完成不适用

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

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Intramyocardial lipid content

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Intramyocardial lipid content

时间窗: 6 months

Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

次要结局

  • Circumferential diastolic strain rate(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven K. Grinspoon, MD

Professor of Medicine

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验