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

Sakata Yasushi0 个研究点目标入组 88 人开始时间: 2022年3月3日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

Sakata Yasushi