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)
- Conditions
- Heart Failure (Heart Failure with Reduced Ejection Fraction)MedDRA version: 20.0Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504835-42-00
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 512
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method