Chronic Heart Failure
Conditions
Keywords
JTT-861, Efficacy, Safety, Tolerability, Chronic Heart Failure, HFrEF, Heart Failure
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.
Interventions
DRUGJTT-861 Capsules
Active drug capsules containing JTT-861
DRUGPlacebo Capsules
Placebo capsules matching in appearance to the active drug capsules
Sponsors
Akros Pharma Inc.
ICON Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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-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 | — |
| 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 | — |
| Post-dose plasma concentrations of JTT-861 | Weeks 2, 4 and 8 | — |
Countries
Bulgaria, Czechia, Poland, Romania, Spain, United States
Outcome results
None listed