Pimobendan in Heart Failure With Preserved Ejection Fraction and Right Ventricular-Pulmonary Arterial Uncoupling - A Randomized Clinical Trial.
Akito Nakagawa, Yuki Matsuoka, Masahiro Seo et al.
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In 30 seconds
The MONACO trial was an adaptive, multicentre, randomised, double-blind, placebo-controlled study of hospitalized patients in Japan with HFpEF and right ventricular–pulmonary arterial uncoupling at discharge. Participants received pimobendan 1.25 mg twice daily or placebo, with exercise capacity assessed by the 6-minute walk test. At day 30, walking distance increased by a mean of 26.9 m with pimobendan and 21.4 m with placebo; the difference was not significant (P=0.402). Enrollment ended after the planned interim analysis was found to be invalid.
Key findings
- At day 30, mean 6-minute walking distance changes were +26.9 m (95% confidence interval; -2.0, +55.8) with pimobendan and +21.4 m (95% confidence interval; -14.3, +57.2) with placebo.
- The between-group difference in change in walking distance was not significant (P=0.402).
- The trial enrolled 50 participants; median age was 82 years and 46% were women.
Why it matters
Right ventricular–pulmonary arterial uncoupling identifies a higher-risk group with HFpEF, making potential therapies of clinical interest. In this trial, short-term pimobendan did not significantly improve measured exercise capacity compared with placebo. The result helps frame expectations for this treatment in the studied population, while the early termination and limited enrollment warrant caution in interpreting the findings.
What to keep in mind
Enrollment was terminated after the planned interim analysis was found to be invalid, and the study assessed exercise capacity over 30 days in a small enrolled group.