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Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial
European Heart Journal ( IF 39.3 ) Pub Date : 2022-08-01 , DOI: 10.1093/eurheartj/ehac389
Theresa Marie Dachs 1 , Franz Duca 1 , René Rettl 1 , Christina Binder-Rodriguez 1 , Daniel Dalos 1 , Luciana Camuz Ligios 1 , Andreas Kammerlander 1 , Ekkehard Grünig 2 , Ingrid Pretsch 3 , Regina Steringer-Mascherbauer 4 , Klemens Ablasser 5 , Manfred Wargenau 6 , Julia Mascherbauer 1, 7 , Irene M Lang 1 , Christian Hengstenberg 1 , Roza Badr-Eslam 1 , Johannes Kastner 1 , Diana Bonderman 1, 8
Affiliation  

Aims The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFpEF). To date, neither established heart failure therapies nor pulmonary vasodilators proved beneficial. This study investigated the efficacy of chronic treatment with the oral soluble guanylate cyclase stimulator riociguat in patients with PH-HFpEF. Methods and Results The phase IIb, randomized, double-blind, placebo-controlled, parallel-group, multicentre DYNAMIC trial assessed riociguat in PH-HFpEF. Patients were recruited at five hospitals across Austria and Germany. Key eligibility criteria were mean pulmonary artery pressure ≥25 mmHg, pulmonary arterial wedge pressure >15 mmHg, and left ventricular ejection fraction ≥50%. Patients were randomized to oral treatment with riociguat or placebo (1:1). Patients started at 0.5 mg three times daily (TID) and were up-titrated to 1.5 mg TID. The primary efficacy endpoint was change from baseline to week 26 in cardiac output (CO) at rest, measured by right heart catheterization. Primary efficacy analyses were performed on the full analysis set. Fifty-eight patients received riociguat and 56 patients placebo. After 26 weeks, CO increased by 0.37 ± 1.263 L/min in the riociguat group and decreased by −0.11 ± 0.921 L/min in the placebo group (least-squares mean difference: 0.54 L/min, 95% confidence interval 0.112, 0.971; P = 0.0142). Five patients dropped out due to riociguat-related adverse events but no riociguat-related serious adverse event or death occurred. Conclusion The vasodilator riociguat improved haemodynamics in PH-HFpEF. Riociguat was safe in most patients but led to more dropouts as compared to placebo and did not change clinical symptoms within the study period.

中文翻译:

Riociguat 治疗射血分数保留的肺动脉高压和心力衰竭:血液动力学试验

目的 肺动脉高压 (PH) 的存在会严重加重射血分数保留型心力衰竭 (HFpEF) 的临床病程。迄今为止,既定的心力衰竭疗法和肺血管扩张剂都没有被证明是有益的。本研究调查了口服可溶性鸟苷酸环化酶刺激剂 riociguat 长期治疗 PH-HFpEF 患者的疗效。方法和结果 IIb 期、随机、双盲、安慰剂对照、平行组、多中心 DYNAMIC 试验评估了 riociguat 在 PH-HFpEF 中的作用。患者在奥地利和德国的五家医院招募。关键的合格标准是平均肺动脉压≥25 mmHg,肺动脉楔压>15 mmHg,左心室射血分数≥50%。患者被随机分配接受 riociguat 或安慰剂 (1:1) 的口服治疗。患者从每天 3 次 (TID) 的 0.5 mg 开始,然后逐渐增加到 1.5 mg TID。主要疗效终点是静息时心输出量 (CO) 从基线到第 26 周的变化,通过右心导管测量。对全分析集进行主要功效分析。58 名患者接受了 riociguat,56 名患者接受了安慰剂。26 周后,riociguat 组 CO 增加 0.37 ± 1.263 L/min,安慰剂组减少 -0.11 ± 0.921 L/min(最小二乘均数差:0.54 L/min,95% 置信区间 0.112, 0.971 ;P = 0.0142)。5 名患者因 riociguat 相关不良事件退出,但未发生 riociguat 相关严重不良事件或死亡。结论血管扩张剂 riociguat 改善了 PH-HFpEF 的血流动力学。
更新日期:2022-08-01
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