Effect of phosphodiesterase-3 inhibition with pimobendan on exercise capacity in heart failure with preserved left ventricular ejection fractio
- Conditions
- HFpEF (heart failure with preserved ejection fraction) with RV-PA uncoupling
- Registration Number
- JPRN-jRCTs051210187
- Lead Sponsor
- Sakata Yasushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 88
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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute difference in the 6-minute walk distance from baseline to 30 days
- Secondary Outcome Measures
Name Time Method [Efficacy endpoint]<br>1) A composite of all-cause death or heart failure readmission at 30 days<br>2) Death (all cause death, cardiac death, non-cardiac death) at 30 days<br>3) Heart failure readmission at 30 days<br>4) Absolute and ralative difference in NT-proBNP from baseline to 30 days<br>5) Absolute and relative difference in echocardiographic parameters (TAPSE/PAST, TAPSE, PASP, e', E/e', LVOT-VTI) from baseline to 30 days<br>6) Absolute and relative difference in ADL and QOL parameters (KCCQ-CSS, EQ5D5L, Barthel index) from baseline to 30 days<br>7) Mean daily non-sedentary daytime activity during the 7days in the end of observational period<br><br>[Safety endpoint]<br>1) Ventricular tachycardia / ventricular fibrillation at 30 days<br>2) Jaundice