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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
314
Active drug capsules containing JTT-861
Placebo capsules matching in appearance to the active drug capsules
Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)
Time frame: 12 Weeks
Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
Time frame: 12 Weeks
Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
Time frame: 12 Weeks
Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
Time frame: 12 Weeks
Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values
Time frame: 12 Weeks
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
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
Time frame: 16 Weeks
Number of subjects with treatment-emergent adverse events
Time frame: Up to 16 Weeks
Trough plasma concentrations of JTT-861
Time frame: Weeks 4, 8 and 12
Post-dose plasma concentrations of JTT-861
Time frame: Weeks 2, 4 and 8
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Arensia Exploratory Medicine Inc.
Phoenix, Arizona, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
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Park Ridge, Illinois, United States
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Hammond, Indiana, United States
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West Monroe, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
...and 65 more locations