Hayashi Hiroya, Ito Shin, Fukuda Hiroki, Sata Makoto, Abe Yukio, Fujimoto Kohei, Fukuda Daiju, Hanajima Yohei, Horii Mutsuo, Ikehara Noriyuki, Inoko Moriaki, Izumi Chisato, Izumiya Yasuhiro, Nakayama Takafumi, Sozu Takashi, Toyoda Shigeru, Watanabe Masafumi, Yokoi Masashi, Kitakaze Masafumi
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center Osaka Japan.
Department of Cardiovascular Medicine, Osaka Metropolitan University Graduate School of Medicine Osaka Osaka Japan.
Circ Rep. 2025 Apr 12;7(5):383-388. doi: 10.1253/circrep.CR-25-0010. eCollection 2025 May 9.
Chronic obstructive pulmonary disease (COPD) is one of the most common comorbidities in patients with chronic heart failure (CHF). A growing number of patients are suffering from both COPD and CHF, and these conditions worsen each other. Inhaled bronchodilator therapy with long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) in combination is currently the mainstay of treatment for COPD. However, the effect of LAMA/LABA on HF with COPD remains unknown.
The COPD-HF trial is a multicenter, double-arm, open-label, exploratory, investigator-initiated clinical study to investigate the effect of LAMA/LABA on HF in patients suffering from both COPD and CHF. The participants are randomly assigned (1 : 1) to the LAMA/LABA (tiotropium+olodaterol FDC (fixed-dose combination) 5/5 ug) group (once a day, 2 inhalations) or non-pharmacological treatments for COPD as a control group. The planned number of patients to be enrolled in this trial is 54 in total (27 in each group). The participants are followed up for 12 weeks with and without LAMA/LABA. The primary endpoint is the change in plasma B-type natriuretic peptide levels from the baseline to the end of this study (12 weeks).
The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.
慢性阻塞性肺疾病（COPD）是慢性心力衰竭（CHF）患者中最常见的合并症之一。越来越多的患者同时患有COPD和CHF，且这两种疾病会相互恶化。吸入长效毒蕈碱拮抗剂（LAMA）和长效β2受体激动剂（LABA）联合支气管扩张剂治疗目前是COPD的主要治疗方法。然而，LAMA/LABA对合并COPD的心力衰竭（HF）的影响尚不清楚。
COPD-HF试验是一项多中心、双臂、开放标签、探索性、研究者发起的临床研究，旨在调查LAMA/LABA对同时患有COPD和CHF的患者HF的影响。参与者被随机分配（1:1）至LAMA/LABA（噻托溴铵+奥达特罗固定剂量组合5/5微克）组（每日一次，吸入2次）或作为对照组的COPD非药物治疗组。本试验计划招募的患者总数为54名（每组27名）。参与者在接受和不接受LAMA/LABA治疗的情况下随访12周。主要终点是从基线到本研究结束（12周）时血浆B型利钠肽水平的变化。
COPD-HF试验将调查LAMA/LABA对合并COPD和CHF患者HF的疗效。
