Heart Failure Clinical Trial
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Summary
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for 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.
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There are 19 Locations for this study
Crystal River Florida, 34429, United States
Hialeah Florida, 33012, United States
Miami Lakes Florida, 33014, United States
Eatonton Georgia, 31024, United States
Park Ridge Illinois, 60068, United States
Hammond Indiana, 46324, United States
Alexandria Louisiana, 71301, United States
West Monroe Louisiana, 71291, United States
Detroit Michigan, 48202, United States
Kew Gardens New York, 11415, United States
Rosedale New York, 11422, United States
Greensboro North Carolina, 27405, United States
Camp Hill Pennsylvania, 17011, United States
Rock Hill South Carolina, 29732, United States
Coppell Texas, 75019, United States
Cypress Texas, 77429, United States
Houston Texas, 77002, United States
Sherman Texas, 75092, United States
Waco Texas, 76712, United States
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