Effects of sildenafil on invasive haemodynamics and exercise capacity in heart failure patients with preserved ejection fraction and pulmonary hypertension: a randomized controlled trial
Effects of sildenafil on invasive haemodynamics and exercise capacity in heart failure patients with preserved ejection fraction and pulmonary hypertension: a randomized controlled trial
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DOI：
10.1093/eurheartj/ehv336
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发表时间：
2015-10-07
影响因子：
39.3
通讯作者：
Voors, Adriaan A.
中科院分区：
文献类型：
--
作者：
Hoendermis, Elke S.;Liu, Licette C. Y.;Voors, Adriaan A.
背景射血分数保留的心力衰竭(HFpEF)，并伴有肺动脉高压，是一个日益严重的医学问题。方法和结果在这项单中心、随机、双盲、安慰剂对照试验中，我们纳入了52例因HFpEF[左心室射血分数(LVEF)和GT；=45%]引起的肺动脉高压[平均肺动脉压(PAP)和肺动脉楔压(PAWP)和肺动脉楔压(PAWP)和GT；15 mm Hg]的患者。患者随机服用PDE-5抑制剂西地那非，每天三次滴定至60毫克，或服用安慰剂12周。主要终点是12周后平均PAP的变化。次要终点是平均PAWP、心输出量和峰值氧耗量(峰值VO2)的变化。平均年龄74±10岁，女性71%，LVEF 58%，NT-proBNP中位数1087(-1945)ng/L。12周后，接受西地那非治疗的患者平均PAP变化为-2.4(95%CI-4.5~-0.3)mm Hg，安慰剂组为-4.7(95%CI-7.1~-2.3)mm Hg(P=0.14)。西地那非对PAWP、心输出量和最大VO2没有有利影响。两组的不良事件总体上具有可比性。结论在我们的研究人群中，西地那非治疗没有降低肺动脉压，也没有改善其他侵袭性血流动力学或临床参数，其特征是HFpEF患者主要表现为孤立的毛细血管后肺动脉高压。(ClinicalTrials.gov，编号NCT01726049)。
Background Heart failure with preserved ejection fraction (HFpEF), with associated pulmonary hypertension is an increasingly large medical problem. Phosphodiesterase (PDE)-5 inhibition may be of value in this population, but data are scarce and inconclusive.Methods and results In this single centre, randomized double-blind, placebo-controlled trial, we included 52 patients with pulmonary hypertension [mean pulmonary artery pressure (PAP)>25 mmHg; pulmonary artery wedge pressure (PAWP)>15 mmHg] due to HFpEF [left ventricular ejection fraction (LVEF) >= 45%]. Patients were randomized to the PDE-5 inhibitor sildenafil, titrated to 60 mg three times a day, or placebo for 12 weeks. The primary endpoint was change in mean PAP after 12 weeks. Secondary endpoints were change in mean PAWP, cardiac output, and peak oxygen consumption (peak VO2). Mean age was 74 +/- 10 years, 71% was female, LVEF was 58%, median NT-proBNP level was 1087 (535-1945) ng/L. After 12 weeks, change in mean PAP was -2.4 (95% CI -4.5 to -0.3) mmHg in patients who received sildenafil, vs. -4.7 (95% CI -7.1 to -2.3) mmHg in placebo patients (P = 0.14). Sildenafil did not have a favourable effect on PAWP, cardiac output, and peak VO2. Adverse events were overall comparable between groups.Conclusion Treatment with sildenafil did not reduce pulmonary artery pressures and did not improve other invasive haemodynamic or clinical parameters in our study population, characterized by HFpEF patients with predominantly isolated post-capillary pulmonary hypertension. (ClinicalTrials.gov, number NCT01726049).