A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects with Heart Failure with Reduced Ejection Fraction (POWER-HF) - AT861-G-22-002

Akros Pharma Inc.0 个研究点目标入组 512 人开始时间: 2023年10月13日最近更新: 2024年7月22日

试验速览

暂无简介。

•Male or female, age 30-85 years (inclusive), at the Screening Visit;, 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 ß-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; Note: In the context of paced rhythm, the underlying cardiac rhythm should be considered when selecting the NT-pro-BNP cutoff level.

•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 worsening 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.

发起方