Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.
研究概览
简要总结
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.
详细描述
clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection fraction < 40%
- •Left ventricular internal dimension >58 mm
- •II-III NYHA class
- •Stable hemodynamic condition during the previous three months
- •Sinus rhythm
排除标准
- •IMA or CABG or PTCA in the previous six months
- •Instable angina
- •Major arrhythmias (Lown class> IV)
- •Diseases limiting exercise capacity
- •Insulin treated diabetes mellitus
结局指标
主要结局
The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.
时间窗: three months
次要结局
- Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.(three months)