Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.
In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.
Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
- •A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
- •Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
- •Age > 18
- •Informed written consent.
- •Reliable anticonception for fertile women.
排除标准
- •Rheumatic disease limiting walking capacity.
- •Exacerbation in COPD during the study.
- •Age>80 years
- •FEV1 < 25 % of predicted.
- •Allergy towards contents of sildenafil or placebo tablets.
- •Fall in blood pressure of > 30 mmHg systolic or >20 mmHg diastolic after intake of the first dose of trial medication.
- •Fall in peripheral saturation of > 5% after intake of the first dose of trial medication.
- •Treatment with nitrous vasodilators or aminophyllamines.
研究组 & 干预措施
1
Sildenafil treatment
干预措施: sildenafil (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
6 minute walk test
时间窗: at base line, after 2 hours and after 3 months
次要结局
- assessment of life quality(At baseline and follow up after three months)
- Systolic pulmonary pressure(At baseline and follow-up after three months)
- Activity of symptoms measured by use of short acting beta agonists(At baseline and follow-up after three months)
- Levels of NT-proBNP and apelin(At baseline and follow-up after three months)
研究者
Charlotte Andersen
MD
University of Aarhus