EUCTR2010-018763-42-GB进行中（未招募）1 期
Do Phosphodiesterase 5 Inhibitors Improve Exercise Capacity in COPD Patients with Pulmonary Hypertension? - The 3P study
niversity of Dundee0 个研究点目标入组 120 人开始时间: 2010年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •INCLUSION CRITERIA
- •Men and women age 35-85 years suffering from moderate to severe COPD (FEV1 <80% of predicted), who are smokers or ex-smokers with a history of at least 20 pack years (GOLD criteria stage II-III). Echocardiography will be used to assess whether they have pulmonary hypertension or not. Two echo criteria will be used. The first one will be right ventricular systolic pressure (RVSP) which is considered equal to systolic pulmonary artery pressure in the absence of pulmonary valve stenosis. RVSP is recommended in guidelines from the ACCP to detect pulmonary hypertension. The precise technique of measuring RVSP by Doppler echocardiography is described by McGoon et al. Briefly, the velocity of the tricuspid regurgitant (TR) jet is calculated (v) and computed along with the right atrial pressure (RAP) as follows: RVSP = 4v2 + RAP. Patients will be included if their RVSP >30mmHg. The reliability of RVSP estimated from echo TR has been studied repeatedly: McGoon et al (2004) quote 10 such studies where echo RVSP correlated well with right heart catheterisations in nine out of these ten studies. Indeed, the ACCP guidelines say In patients with a clinical suspicion of pulmonary hypertension, Doppler echocardiography should be performed to evaluate the level of RVSP”. However, RVSP is only able to be calculated in 60-70% of COPD cases and an alternative is the pulmonary acceleration time which is a measure of mean pulmonary artery pressure (MPAP). This is obtainable in 40-50% of COPD individuals in our experience. It has good reproducibility and correlates well with catheter derived measures. Prof Lipworth (co-applicant) has been using both measures for over 10 years. Cardiac output will also be assessed echocardiographically. For inclusion, patients will need to have a reduced pulmonary acceleration time (<120 ms) which equates to an MPAP >20 mmHg. Since these two echo measures should be very close, we will recruit only those with an RVSP >30 mmHg and a pulmonary acceleration time <120 ms, although if one of these measures is unmeasurable, they can be recruited on the basis of the other one alone. This is a pragmatic approach reflecting that the real world of clinical practice/research is not the same as the ideal world. Patients with fluid retention (Cor Pulmonale) will be recruitable as long as they appear euvolaemic on clinical examination due to diuretic therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •EXCLUSION CRITERIA
- •Pulmonary stenosis or echo LV outflow obstruction or LV systolic dysfunction (LVEF <45%). Patients taking nitrates, nicorandil or doxazosin will also be excluded. Other standard contraindications for such drugs will apply, e.g. systolic BP <90 mmHg, recent stroke, unstable angina, past history of non arteritic anterior ischaemic optic neuropathy. With all these exclusions applied, PDE5A inhibitors such as tadalafil are regarded as safe.
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