ISRCTN10877141已完成2 期
Do phosphodiesterase-5 inhibitors improve exercise capacity in COPD patients with pulmonary hypertension?: a double-blind, randomised, placebo-controlled trial
niversity of Dundee (UK)0 个研究点目标入组 120 人开始时间: 2010年10月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 08/10/2012:
- •1. Male or female participants, aged between 35 to 85 inclusive
- •3. Forced Expiratory Volume in one second (FEV1) <80% predicted (protocol change approved 18/02/2011)
- •4. Right Ventricular Systolic Pressure (RVSP) >30mmHg and/or pulmonary acceleration time <120 ms
- •Previous inclusion criteria until 08/10/2012:
- •1. Male or female participants, aged between 35 to 85 inclusive
- •2. Diagnosis of COPD or Emphysema (diagnosis of emphysema removed due to an error in the original application)
- •3. Forced Expiratory Volume in one second (FEV1) <50% predicted
- •4. Smoker or ex-smoker with a history = 20 pack years (removed due to protocol change approved 23/01/2012)
- •5. Right Ventricular Systolic Pressure (RVSP) >30mmHg and/or pulmonary acceleration time <120 ms
- •6. Plasma Brain Natriuretic Peptide (BNP) level >25 pg/ml (removed due to protocol change approved 18/02/2011)
排除标准
- •1. Pulmonary stenosis
- •2. Echo Left Ventricular (LV) outflow obstruction
- •3. LV systolic dysfunction (LVEF <45%)
- •4. Patients taking nitrates, nicorandil or doxazosin
- •5. Systolic blood pressure (BP) <90 mmHg, recent stroke, unstable angina, past history of non arteritic anterior ischaemic optic neuropathy
研究者
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