Effect of phosphodiesterase-3 inhibition with pimobendan on exercise capacity in heart failure with preserved left ventricular ejection fraction

Effect of phosphodiesterase-3 inhibition with pimobendan on exercise capacity in heart failure with preserved left ventricular ejection fraction and right ventricular-vascular uncoupling: a prospective multicenter double-blind placebo-controlled randomized - MONACO trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051210187

Enrollment

Registered

2022-03-03

Start date

2022-03-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HFpEF (heart failure with preserved ejection fraction) with RV-PA uncoupling

Interventions

Experimental arm pimobendan 1.25mg bid plus standard therapy Control arm Placebo bid plus standard therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hospital admission due to acute decompensated heart failure according to the Framingham heart failure diagnostic criteria. 2) In a stable condition 1-3 days after the completion of acute phase treatment for HF, all of the following criteria to be met. a. left ventricular ejection fraction >-50% (m-Simpson or Teichholz) b. NT-proBNP >- 125/365 pg/mL (sinus rhythm/atrial fibrillation) c. LAVI > 34/40 mL/m2 (sinus rhythm/atrial fibrillation) or LVMI >-115/95 g/m2 (male/female) or E/e' > 9 d. TAPSE/PASP - 20 years

Exclusion criteria

Exclusion criteria: (1)Unable or inappropriate to measure TAPSE/PASP (2)Oral inotropic agent use (3)Pulmonary vasodilator use (4)Myocardial infarction within 90 days before consent (5)Severe valvular disease (6)Cardiac amyloidosis or hypertrophic cardiomyopathy (7)Patients with a history of overtly reduced LVEF (-7) (14)Plan to undergo elective revascularization, pacemaker implantation, or catheter ablation during the study period. (15)Patients inappropriate for the study participation in the opinion of the investigators

Design outcomes

Primary

Measure	Time frame
Absolute difference in the 6-minute walk distance from baseline to 30 days	—

Secondary

Measure	Time frame
[Efficacy endpoint] 1) A composite of all-cause death or heart failure readmission at 30 days 2) Death (all cause death, cardiac death, non-cardiac death) at 30 days 3) Heart failure readmission at 30 days 4) Absolute and ralative difference in NT-proBNP from baseline to 30 days 5) Absolute and relative difference in echocardiographic parameters (TAPSE/PAST, TAPSE, PASP, e', E/e', LVOT-VTI) from baseline to 30 days 6) Absolute and relative difference in ADL and QOL parameters (KCCQ-CSS, EQ5D5L, Barthel index) from baseline to 30 days 7) Mean daily non-sedentary daytime activity during the 7days in the end of observational period [Safety endpoint] 1) Ventricular tachycardia / ventricular fibrillation at 30 days 2) Jaundice	—

Measure

Time frame

[Efficacy endpoint] 1) A composite of all-cause death or heart failure readmission at 30 days 2) Death (all cause death, cardiac death, non-cardiac death) at 30 days 3) Heart failure readmission at 30 days 4) Absolute and ralative difference in NT-proBNP from baseline to 30 days 5) Absolute and relative difference in echocardiographic parameters (TAPSE/PAST, TAPSE, PASP, e', E/e', LVOT-VTI) from baseline to 30 days 6) Absolute and relative difference in ADL and QOL parameters (KCCQ-CSS, EQ5D5L, Barthel index) from baseline to 30 days 7) Mean daily non-sedentary daytime activity during the 7days in the end of observational period [Safety endpoint] 1) Ventricular tachycardia / ventricular fibrillation at 30 days 2) Jaundice

—

Contacts

Public ContactYohei Sotomi

Osaka University Hospital

yohei.sotomi@cardiology.med.osaka-u.ac.jp+81-6-6879-3631

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026