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

JRCT ID: jRCTs051210187

Registered date:03/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: HFpEF (heart failure with preserved ejection fraction) with RV-PA uncoupling
• Date of first enrollment: 03/03/2022
• Target sample size: 88
• Study type: Interventional
• Intervention(s): Experimental arm pimobendan 1.25mg bid plus standard therapy Control arm Placebo bid plus standard therapy

Outcome(s)

• Primary Outcome: Absolute difference in the 6-minute walk distance from baseline to 30 days

Secondary Outcome

[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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 < 0.57 mm/mmHg
3) Patients who can give written informed consent during hospitalization.
4) Age >- 20 years

Exclude 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 (<-40%)
(8)Patients with a history of cardiac surgery within 60 days bofore enrollment
(9)Hemoglobin level < 8.0 g/dL
(10)Hemodialysis
(11)Patient with a history of VT/VF or ICD implantation
(12)Heart transplantation
(13)Unable to perform 6-minute walk test (Clinical Frailty Scale>-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

Related Information

• Primary Sponsor: Sakata Yasushi
• Source(s) of Monetary Support: TOA EIYO LTD.