Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction (POWER-HF)
Chronic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring JTT-861, Efficacy, Safety, Tolerability, Chronic Heart Failure, HFrEF, Heart Failure
Eligibility Criteria
Inclusion Criteria: Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit; Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit; Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated); Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit; Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit. Exclusion Criteria: Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit; Has a history of coronary revascularization (percutaneous coronary intervention [PCI] and/or coronary artery bypass graft [CABG]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit); Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit; Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis; Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit; Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit.
Sites / Locations
- East Texas Cardiology PARecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
JTT-861 Dose 1
JTT-861 Dose 2
Placebo
JTT-861 Capsules Dose 1 orally once daily for 12 weeks
JTT-861 Capsules Dose 2 orally once daily for 12 weeks
Placebo Capsules orally once daily for 12 weeks