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Peer-reviewedCC BY-NC-NDCirculation Journal

Pimobendan in Heart Failure With Preserved Ejection Fraction and Right Ventricular–Pulmonary Arterial Uncoupling ― A Randomized Clinical Trial ―

12 more authors

Abstract

BACKGROUND: Patients with heart failure with preserved ejection fraction (HFpEF) and right ventricular (RV)-pulmonary arterial (PA) uncoupling, as assessed by a decrease ratio of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) on echocardiography, have poorer outcomes than patients without RV-PA uncoupling. METHODS AND RESULTS: The MONACO trial was an adaptive, randomized, double-blind, placebo-controlled study that enrolled hospitalized patients with HFpEF admitted to 12 centers in Japan. Patients who had left ventricular ejection fraction ≥50% and TAPSE/PASP <0.57 mm/mmHg at discharge were randomized 1 : 1 to receive pimobendan 1.25 mg b.i.d. or placebo. The primary objective was to evaluate changes from baseline (day 0) to day 30 in exercise capacity measured by the 6-minute walking test. Enrollment was terminated due to the invalid result of the planned interim analysis. The median age of participants was 82 years and 46% were women. Pimobendan (n=24) or placebo (n=26) was administrated orally. At day 30, mean changes in 6-minute walking distance in patients who received pimobendan (+26.9 m [95% confidence interval; -2.0, +55.8]) or placebo (+21.4 m [95% confidence interval; -14.3, +57.2]) were not significantly different (P=0.402). CONCLUSIONS: Among patients with HFpEF and RV-PA uncoupling, administration of pimobendan for 30 days did not result in significant improvement in exercise capacity compared with placebo.

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BibTeX
@article{nakagawa2026pimobendan,
  title = {{Pimobendan in Heart Failure With Preserved Ejection Fraction and Right Ventricular–Pulmonary Arterial Uncoupling ― A Randomized Clinical Trial ―}},
  author = {Akito Nakagawa and Yuki Matsuoka and Masahiro Seo and Haruhiko Abe and Yusuke Nakagawa and Takeshi Masaki and Shinichiro Suna and Yasuhiro Akazawa and Kei Nakamoto and Toshiaki Mano and Masamichi Yano and Masayuki Hirai and Katsuomi Iwakura and Toshiaki Yokoi and Tomomi Yamada and Satomi Okamura and Takahisa Yamada and Yoshio Yasumura and Akihiro Sunaga and Katsuki Okada and Daisaku Nakatani and Yohei Sotomi and Shungo Hikoso and Yasushi Sakata},
  journal = {Circulation Journal},
  year = {2026},
  month = oct,
  doi = {10.1253/circj.cj-26-0152},
  url = {https://www.jstage.jst.go.jp/article/circj/90/11/90_CJ-26-0152/_article},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Pimobendan in Heart Failure With Preserved Ejection Fraction and Right Ventricular–Pulmonary Arterial Uncoupling ― A Randomized Clinical Trial ―
AU  - Akito Nakagawa
AU  - Yuki Matsuoka
AU  - Masahiro Seo
AU  - Haruhiko Abe
AU  - Yusuke Nakagawa
AU  - Takeshi Masaki
AU  - Shinichiro Suna
AU  - Yasuhiro Akazawa
AU  - Kei Nakamoto
AU  - Toshiaki Mano
AU  - Masamichi Yano
AU  - Masayuki Hirai
AU  - Katsuomi Iwakura
AU  - Toshiaki Yokoi
AU  - Tomomi Yamada
AU  - Satomi Okamura
AU  - Takahisa Yamada
AU  - Yoshio Yasumura
AU  - Akihiro Sunaga
AU  - Katsuki Okada
AU  - Daisaku Nakatani
AU  - Yohei Sotomi
AU  - Shungo Hikoso
AU  - Yasushi Sakata
PY  - 2026
DA  - 2026/10/23
JO  - Circulation Journal
DO  - 10.1253/circj.cj-26-0152
UR  - https://www.jstage.jst.go.jp/article/circj/90/11/90_CJ-26-0152/_article
AB  - BACKGROUND: Patients with heart failure with preserved ejection fraction (HFpEF) and right ventricular (RV)-pulmonary arterial (PA) uncoupling, as assessed by a decrease ratio of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) on echocardiography, have poorer outcomes than patients without RV-PA uncoupling. METHODS AND RESULTS: The MONACO trial was an adaptive, randomized, double-blind, placebo-controlled study that enrolled hospitalized patients with HFpEF admitted to 12 centers in Japan. Patients who had left ventricular ejection fraction ≥50% and TAPSE/PASP <0.57 mm/mmHg at discharge were randomized 1 : 1 to receive pimobendan 1.25 mg b.i.d. or placebo. The primary objective was to evaluate changes from baseline (day 0) to day 30 in exercise capacity measured by the 6-minute walking test. Enrollment was terminated due to the invalid result of the planned interim analysis. The median age of participants was 82 years and 46% were women. Pimobendan (n=24) or placebo (n=26) was administrated orally. At day 30, mean changes in 6-minute walking distance in patients who received pimobendan (+26.9 m [95% confidence interval; -2.0, +55.8]) or placebo (+21.4 m [95% confidence interval; -14.3, +57.2]) were not significantly different (P=0.402). CONCLUSIONS: Among patients with HFpEF and RV-PA uncoupling, administration of pimobendan for 30 days did not result in significant improvement in exercise capacity compared with placebo.
SN  - 1347-4820
SN  - 1346-9843
ER  -