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 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 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 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 (49)
Waco Cardiology Associates - NextStage Clinical Research
🇺🇸Waco, Texas, United States
Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD
🇧🇬Burgas, Bulgaria
University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD
🇧🇬Pleven, Bulgaria
Multiprofile Hospital For Active Treatment Heart and Brain EAD
🇧🇬Pleven, Bulgaria
Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Center Convex EOOD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
🇧🇬Stara Zagora, Bulgaria
Medicus Services s.r.o.
🇨🇿Brandýs nad Labem, Czech Republic
Fakultní nemocnice u sv. Anny v Brně
🇨🇿Brno, Czech Republic
Centrum pro zdraví, s.r.o.
🇨🇿Brno, Czech Republic
Vojenská nemocnice Brno
🇨🇿Brno, Czech Republic
Fakultní nemocnice Brno
🇨🇿Brno, Czech Republic
Fakultní nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czech Republic
Kardio Brynów Sp. z o.o.
🇵🇱Katowice, Poland
Trialmed CRS Piotrków Trybunalski
🇵🇱Piotrków Trybunalski, Poland
Clinmedica Research Sp. z o.o.
🇵🇱Skierniewice, Poland
NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
🇵🇱Sopot, Poland
4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
🇵🇱Wrocław, Poland
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
🇷🇴Brașov, Romania
Spitalul Clinic De Urgență Sf. Pantelimon București
🇷🇴București, Romania
Spitalul Universitar de Urgență București
🇷🇴București, Romania
Mat Cord Biomedica SRL
🇷🇴Buzău, Romania
Cardio Med SRL
🇷🇴Târgu Mureș, Romania
Spitalul Clinic Județean de Urgență Craiova
🇷🇴Craiova, Romania
CMI Dr. Podoleanu Cristian
🇷🇴Târgu Mureș, Romania
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Santiago
🇪🇸A Coruña, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Monroe Research, LLC
🇺🇸West Monroe, Louisiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Laurelton Heart Specialist P.C.
🇺🇸Rosedale, New York, United States
Pharma Medical Innovation, Inc.
🇺🇸Miami Lakes, Florida, United States
D and H Tamarac Research Center, LLC
🇺🇸Tamarac, Florida, United States
Affinity Health
🇺🇸Park Ridge, Illinois, United States
ASHA Clinical Research-Munster, LLC
🇺🇸Hammond, Indiana, United States
Cambridge Medical Trials
🇺🇸Alexandria, Louisiana, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Onsite Clinical Solutions, LLC
🇺🇸Rock Hill, South Carolina, United States
Prime Revival Research Institute, LLC
🇺🇸Coppell, Texas, United States
Cypress Heart and Vascular Center
🇺🇸Cypress, Texas, United States
East Texas Cardiology PA
🇺🇸Houston, Texas, United States