NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210187

Registered date:03/03/2022

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

Basic Information

Recruitment status Suspended
Health condition(s) or Problem(s) studiedHFpEF (heart failure with preserved ejection fraction) with RV-PA uncoupling
Date of first enrollment03/06/2022
Target sample size88
Countries of recruitment
Study typeInterventional
Intervention(s)Experimental arm pimobendan 1.25mg bid plus standard therapy Control arm Placebo bid plus standard therapy

Outcome(s)

Primary OutcomeAbsolute 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 maximumNot applicable
GenderBoth
Include criteria1) 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

Contact

Public contact
Name Yohei Sotomi
Address 2-15 Yamadaoka, Suita Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3631
E-mail yohei.sotomi@cardiology.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Yasushi Sakata
Address 2-15 Yamadaoka, Suita Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3631
E-mail yasushisk@cardiology.med.osaka-u.ac.jp
Affiliation Osaka University Hospital