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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT06017609

Recruitment Status:

Recruiting

Sponsor:

Akros Pharma Inc.

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There are 19 Locations for this study

See Locations Near You

Nature Coast Clinical Research
Crystal River Florida, 34429, United States
Indago Research & Health Center, Inc.
Hialeah Florida, 33012, United States
Pharma Medical Innovation, Inc.
Miami Lakes Florida, 33014, United States
Accel Research Site Network - Cardiology Care Clinic
Eatonton Georgia, 31024, United States
Affinity Health
Park Ridge Illinois, 60068, United States
ASHA Clinical Research-Munster, LLC
Hammond Indiana, 46324, United States
Cambridge Medical Trials
Alexandria Louisiana, 71301, United States
Monroe Research, LLC
West Monroe Louisiana, 71291, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Marian David, MD, PC
Kew Gardens New York, 11415, United States
Laurelton Heart Specialist P.C.
Rosedale New York, 11422, United States
Medication Management, LLC
Greensboro North Carolina, 27405, United States
Capital Area Research, LLC
Camp Hill Pennsylvania, 17011, United States
Onsite Clinical Solutions, LLC
Rock Hill South Carolina, 29732, United States
Prime Revival Research Institute, LLC
Coppell Texas, 75019, United States
Cypress Heart and Vascular Center
Cypress Texas, 77429, United States
East Texas Cardiology PA
Houston Texas, 77002, United States
Sherman Clinical Research
Sherman Texas, 75092, United States
Waco Cardiology Associates - NextStage Clinical Research
Waco Texas, 76712, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT06017609

Recruitment Status:

Recruiting

Sponsor:


Akros Pharma Inc.

How clear is this clinincal trial information?

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