The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- pulmonary artery pressure
研究概览
简要总结
Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable for over 1 month
- •mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
- •never received target therapy before
排除标准
- •Patients with other serious respiratory diseases
- •Patients with pulmonary hypertension other than group 3
- •Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
- •Patients with limited life expectancy
- •Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
- •Psychopath or addict
- •Nonstable patients with type Ⅰor Ⅱ respiratory failure
- •Patients with contraindication for sildenafil
- •Patients in pregnancy or breastfeeding
研究组 & 干预措施
Interventional group
Sildenafil Citrate, 20mg, tid for 12 weeks
干预措施: Sildenafil Citrate (Drug)
Control group
placebo oral tablet, 12 weeks
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
pulmonary artery pressure
时间窗: 12 weeks
pressure in mmHg
pulmonary vascular resistance
时间窗: 12 weeks
woods
次要结局
未报告次要终点
研究者
Jianguo He
Chief of Pulmonary Vascular Disease Center
Chinese Academy of Medical Sciences, Fuwai Hospital