Status:
RECRUITING
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
Akros Pharma Inc.
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
30-85 years
Phase:
PHASE2
Brief 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) w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06017609
Start Date
December 20 2023
End Date
February 1 2027
Last Update
October 14 2025
Active Locations (75)
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1
Arensia Exploratory Medicine Inc.
Phoenix, Arizona, United States, 85015
2
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
3
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
4
Med Research of Florida
Miami, Florida, United States, 33186