NCT01197469已完成2 期
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 6 minute walking distance
研究概览
简要总结
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced expiratory volume in 1 second (FEV1) <80% (FEV1/FVC <0.70)
- •Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time <120 ms
排除标准
- •Pulmonary stenosis or echo left ventricular outflow tract obstruction
- •Left ventricular ejection fraction < 45%
- •Patients taking nitrates, nicorandil or doxazosin.
- •Drug contraindications:
- •Systolic Blood Pressure <90 mmHg
- •recent stroke
- •unstable angina
- •past history of non arteritic anterior ischaemic optic neuropathy
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Tadalafil
Active Comparator
干预措施: Tadalafil (Drug)
结局指标
主要结局
6 minute walking distance
时间窗: 3 months
The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
次要结局
- B- Natriuretic Peptide (BNP)(3 months)
- Diffusion lung capacity for carbon monoxide (DLCO)(3 months)
- Echocardiographic measurements(3 months)
- Quality of Life(3 months)
研究者
A. D. Struthers
Chief Investigator
University of Dundee
研究点 (1)
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