Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
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
- 否
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
Steven K. Grinspoon, MD
Professor of Medicine
Massachusetts General Hospital
