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Publications

Journal Article Epublish

PubMed: 40352126 DOI: 10.1253/circrep.CR-25-0010

Rationale and Design of an Exploratory, Randomized, Open-Label, Multicenter Clinical Trial to Investigate the Efficacy of Long-Acting β2-Agonist/Long-Acting Muscarinic Antagonist on Heart Failure Complicated by Chronic Obstructive Pulmonary Disease (COPD-HF Trial).

Circ Rep 7(5):383-388

Authors: Hiroya Hayashi, Shin Ito, Hiroki Fukuda, Makoto Sata, Yukio Abe, Kohei Fujimoto, Daiju Fukuda, Yohei Hanajima, Mutsuo Horii, Noriyuki Ikehara, Moriaki Inoko, Chisato Izumi, Yasuhiro Izumiya, Takafumi Nakayama, Takashi Sozu, Shigeru Toyoda, Masafumi Watanabe, Masashi Yokoi, Masafumi Kitakaze

Affiliations

  • 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.
  • Department of Clinical Research and Development, National Cerebral and Cardiovascular Center Osaka Japan.
  • Department of Heart Failure and Transplantation, National Cerebral and Cardiovascular Center Osaka Japan.
  • Cardiovascular Center, Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai Osaka Japan.
  • Division of Pulmonology and Infection Control, National Cerebral and Cardiovascular Center Osaka Japan.
  • Department of Cardiology, Osaka City General Hospital Osaka Japan.
  • Department of Cardiovascular Medicine, Ishikiriseiki Hospital Osaka Japan.
  • Division of Cardiology, Yokohama City University Medical Center Yokohama Japan.
  • Department of Cardiology, Nagoya City University West Medical Center Nagoya Japan.
  • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University Kumamoto Japan.
  • Department of Cardiology, Nagoya City University Graduate School of Medical Sciences Nagoya Japan.
  • Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science Tokyo Japan.
  • Department of Cardiovascular Medicine, Dokkyo Medical University Tochigi Japan.
  • Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine Yamagata Japan.
  • Hanwa Memorial Hospital Osaka Japan.
  • Non-Profit Organization Think of Medicine in Science Osaka Japan.
  • The Osaka Medical Research Foundation for Intractable Diseases Osaka Japan.

Abstract

Background

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.

Methods and Results

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).

Conclusions

The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.

MeSH

Heart Failure, Heart, Muscarinic Antagonists, Pulmonary Disease, Chronic Obstructive, Therapeutics, Lung Diseases, Lung Diseases, Obstructive