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临床试验/NCT00491803
NCT00491803已完成4 期

Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Reduction of mean PAP and PVR

研究概览

简要总结

Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects.

It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD (FEV1/FVC<0.7)
  • Age 40-75
  • Pulmonary hypertension (Vmax TI>=2.8m/sec)

排除标准

  • Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors
  • Coronary disease
  • Ischemic optical neuritis

研究组 & 干预措施

2

Active Comparator

Sildenafil 40mg

干预措施: Sildenafil (Drug)

1

Active Comparator

Sildenafil 20mg

干预措施: Sildenafil (Drug)

结局指标

主要结局

Reduction of mean PAP and PVR

时间窗: 60 minutes

次要结局

  • CO, PaO2, V/Q(60 minutes)

研究者

申办方类型
Other

研究点 (1)

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