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: 2016年10月17日

适应症

试验速览

暂无简介。

•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)

•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

发起方

niversity of Dundee (UK)