Phase 2 Study to Evaluate the Efficacy and Safety of Inhaled Nitric Oxide Therapy in Patients With Severe Right Heart Failure Associated With Pulmonary Hypertension - Protocol for the PHiNO Study.

Circulation reports Pub Date : 2025-02-11 eCollection Date: 2025-04-10 DOI:10.1253/circrep.CR-24-0125
Jin Ueda, Akihiro Tsuji, Tatsuo Aoki, Ryotaro Asano, Takatoyo Kiko, Hiroya Hayashi, Hiroyuki Endo, Naruhiro Nishi, Ryo Takano, Shinya Fujisaki, Mitsumasa Akao, Koko Asakura, Haruko Yamamoto, Takeshi Ogo
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Abstract

Background: Acute right heart failure (RHF) is a syndrome characterized by sudden right ventricular dysfunction leading to systemic hypoperfusion, which carries a poor prognosis, particularly in patients with pulmonary hypertension (PH). Early reduction of pulmonary vascular resistance (PVR) is crucial for improving RHF and reducing acute mortality. Compared with pulmonary vasodilators approved for pulmonary arterial hypertension (PAH) and chronic thromboembolic PH (CTEPH), inhaled nitric oxide (iNO) therapy has the advantages of being fast acting, an excellent selective pulmonary vasodilation, and has less effect on systemic blood pressure.

Methods and results: We describe a phase II, investigator-initiated, randomized, open-label trial (Japan Registry of Clinical Trials jRCT2051220042) to evaluate the efficacy and safety of iNO therapy (INOflo® for inhalation 800 ppm), as an acute-phase treatment for severe RHF associated with PAH or CTEPH over a 1-week course. Thirty patients will be enrolled and randomized to receive the study drug, or not, in addition to conventional therapy. The primary endpoint is the change in PVR from baseline to 30 min after the start of inhalation, measured using right heart catheterization. Secondary endpoints include changes in hemodynamic parameters, arterial blood tests, and echocardiography findings, and the safety of iNO therapy, assessed through blood methemoglobin concentration, blood pressure, and adverse events.

Conclusions: iNO therapy is expected to play a significant role in rapidly improving acute severe RHF associated with PH.

评估吸入一氧化氮治疗严重右心衰伴肺动脉高压患者的有效性和安全性的2期研究- PHiNO研究方案
背景:急性右心衰(Acute right heart failure, RHF)是一种以突发性右心室功能障碍导致全身灌注不足为特征的综合征,预后较差,尤其是肺动脉高压(pulmonary hypertension, PH)患者。早期降低肺血管阻力(PVR)对于改善RHF和降低急性死亡率至关重要。与批准用于肺动脉高压(PAH)和慢性血栓栓塞性PH (CTEPH)的肺血管扩张剂相比,吸入型一氧化氮(iNO)治疗具有作用快、选择性肺血管扩张性好、对全身血压影响小等优点。方法和结果:我们描述了一项II期,研究者发起的,随机的,开放标签的试验(日本临床试验注册中心jRCT2051220042),以评估iNO治疗(吸入800 ppm的INOflo®)的有效性和安全性,作为1周疗程的急性期治疗与PAH或CTEPH相关的严重RHF。30名患者将被招募,并随机接受或不接受研究药物,以及常规治疗。主要终点是PVR从基线到开始吸入后30分钟的变化,使用右心导管测量。次要终点包括血流动力学参数、动脉血检查和超声心动图结果的变化,以及通过血高铁血红蛋白浓度、血压和不良事件评估的iNO治疗的安全性。结论:iNO治疗有望在快速改善急性严重RHF合并PH中发挥重要作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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