NCT00182169已完成2 期
Randomized, Placebo Control, Clinical Trial Evaluating the Effect of Human Recombinant Growth Hormone in Patients With Severe Congestive Heart Failure. The Growth Hormone In Heart Failure Trial (GIFT)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
研究概览
简要总结
Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of < 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on "CHF" therapy at the time of randomization.
排除标准
- •Exercise limited by claudication, angina, neurological, pulmonary (FEV1 < 50%; FVC < 50%), or musculoskeletal disease.
- •Active known malignancy; remission of < 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
- •Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
- •Any other non-cardiac condition that substantially decreases survival.
- •Significant valvular stenosis or hypertrophic cardiomyopathy.
- •Unable to comply with GH injection.
- •Pregnancy or women of child bearing age not using adequate contraceptive means.
- •Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
- •Cor pulmonale.
- •Acute myocarditis.
- •Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
- •Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH > 7 or < 0.2) at screening.
- •Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
- •Sustained ventricular tachycardia (lasting > 30 seconds) on screening Holter.
- •Significant liver disease (INR>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase > 3X upper limit of normal; or bilirubin > 2X the upper limit of normal) at baseline.
- •Failure to give informed consent
结局指标
主要结局
6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
次要结局
- Cardiac Function measured with radionuclide angiography and echocardiography
- Exercise capacity measured during treadmill testing (duration of exercise)
- Quality of life measured with Minnesota Living with Heart Failure
- Neurohormones
- baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
研究者
研究点 (2)
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