Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
- Conditions
- Chronic Heart Failure
- Interventions
- Drug: JTT-861 CapsulesDrug: Placebo Capsules
- Registration Number
- NCT06017609
- Lead Sponsor
- Akros Pharma Inc.
- 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) who are on a stable, guideline-directed medical therapy for heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JTT-861 Dose 1 JTT-861 Capsules JTT-861 Capsules Dose 1 orally once daily for 12 weeks JTT-861 Dose 2 JTT-861 Capsules JTT-861 Capsules Dose 2 orally once daily for 12 weeks Placebo Placebo Capsules Placebo Capsules orally once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo 12 Weeks Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values 12 Weeks Post-dose plasma concentrations of JTT-861 Weeks 2, 4 and 8 Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo) 12 Weeks Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo 12 Weeks Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo 12 Weeks Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline 16 Weeks General Scoring Guideline: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Number of subjects with treatment-emergent adverse events Up to 16 Weeks Trough plasma concentrations of JTT-861 Weeks 4, 8 and 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Arensia Exploratory Medicine Inc.
🇺🇸Phoenix, Arizona, United States
Med Research of Florida
🇺🇸Miami, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Profound Research LLC
🇺🇸Farmington Hills, Michigan, United States
NextStage Clinical Research - (Kansas City [01])
🇺🇸Kansas City, Missouri, United States
Multiprofile Hospital for Active Treatment "Ivan Skenderov"
🇧🇬Gotse Delchev, Bulgaria
Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD
🇧🇬Gotse Delchev, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Scroll for more (58 remaining)Arensia Exploratory Medicine Inc.🇺🇸Phoenix, Arizona, United States