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首页> 外文期刊>Pulmonary Circulation >Study Design and Rationale for Investigating Phosphodiesterase type 5 Inhibition for the Treatment of Pulmonary Hypertension Due to Chronic Obstructive Lung Disease: The TADA-PHiLD (TADAlafil for Pulmonary Hypertension Associated with Chronic Obstructive Lung Disease) Trial:
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Study Design and Rationale for Investigating Phosphodiesterase type 5 Inhibition for the Treatment of Pulmonary Hypertension Due to Chronic Obstructive Lung Disease: The TADA-PHiLD (TADAlafil for Pulmonary Hypertension Associated with Chronic Obstructive Lung Disease) Trial:

机译：研究5型磷酸二酯酶抑制作用治疗慢性阻塞性肺疾病引起的肺动脉高压的研究设计和理论基础：TADA-PHiLD（TADAlafil用于与慢性阻塞性肺疾病相关的肺动脉高压）试验：

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In patients with chronic obstructive pulmonary disease (COPD), moderate or severe pulmonary hypertension (COPD-PH) is associated with increased rates of morbidity and mortality. Despite this, approaches to treatment and the efficacy of phosphodiesterase type 5 inhibition (PDE-5i) in COPD-PH are unresolved. We present the clinical rationale and study design to assess the effect of oral tadalafil on exercise capacity, cardiopulmonary hemodynamics, and clinical outcome measures in COPD-PH patients. Male and female patients 40–85 years old with GOLD stage 2 COPD or higher and pulmonary hypertension diagnosed on the basis of invasive cardiac hemodynamic assessment (mean pulmonary artery pressure [mPAP] 30 mmHg, pulmonary vascular resistance [PVR] 2.5 Wood units, and pulmonary capillary wedge pressure ≤18 mmHg at rest) will be randomized at a 1:1 ratio to receive placebo or oral PDE-5i with tadalafil (40 mg daily for 12 months). The primary end point is change from baseline in 6-minute walk distance at 12 months. The secondary end points are change from baseline in PVR and mPAP at 6 months and change from baseline in peak volume of oxygen consumption (V·o2) during exercise at 12 months. Changes in systemic blood pressure and/or oxyhemoglobin saturation (SaO2) at rest and during exercise will function as safety outcome measures. TADA-PHiLD (TADAlafil for Pulmonary Hypertension assocIated with chronic obstructive Lung Disease) is the first sufficiently powered randomized clinical trial testing the effect of PDE-5i on key clinical and drug safety outcome measures in patients with at least moderate PH due to COPD.
机译：在患有慢性阻塞性肺疾病（COPD）的患者中，中度或重度肺动脉高压（COPD-PH）与发病率和死亡率增加相关。尽管如此，COPD-PH中的治疗方法和5型磷酸二酯酶抑制作用（PDE-5i）仍未解决。我们提出了临床依据和研究设计，以评估口服他达拉非对COPD-PH患者运动能力，心肺血流动力学和临床结局指标的影响。 40岁至85岁，GOLD 2期COPD或更高和患有肺动脉高压的男性和女性患者，根据有创心脏血液动力学评估（平均肺动脉压[mPAP]> 30 mmHg，肺血管阻力[PVR]> 2.5伍德单位）诊断，并且肺毛细血管楔形压力≤18mmHg（静息时））将以1：1的比例随机分配，以接受安慰剂或口服他达拉非的PDE-5i（每天40 mg，持续12个月）。主要终点是在12个月步行6分钟后距基线的变化。次要终点是6个月时PVR和mPAP的基线变化，以及运动12个月时的最大耗氧量（V·o2）偏离基线。休息时和运动过程中全身血压和/或氧合血红蛋白饱和度（SaO2）的变化将作为安全性指标。 TADA-PHiLD（TADAlafil用于与慢性阻塞性肺疾病相关的肺动脉高压）是第一个充分有力的随机临床试验，用于测试PDE-5i对COPD至少为中度PH的患者的关键临床和药物安全性结果指标的影响。

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