Heart Failure (Heart Failure with Reduced Ejection Fraction)
Conditions
Brief summary
Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o LVEF as assessed by two-dimensional echocardiography (2D-echo) o Left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo o Left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo, Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o Left atrial volume (LAV) as assessed by 2D-echo o NT-pro-BNP o Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, Pharmacokinetic (PK) Parameters • JTT-861 trough plasma concentrations at Weeks 4, 8 and 12 • JTT-861 plasma concentrations (post-dose) at Weeks 2, 4 and 8, Safety Parameters • Number of subjects with adverse events (AEs), change from baseline in safety laboratory, vital signs and 12-lead electrocardiogram (ECG) parameters.
Detailed description
Exploratory Efficacy Parameters • Change from baseline to EOT in: o eGFR o Cystatin C o Urine albumin-to-creatinine ratio (ACR) o Hemoglobin A1c (HbA1c) and plasma glucose, Exploratory Efficacy Parameters • Change from baseline to EOT in: o Tricuspid annular plane systolic excursion (TAPSE) as assessed by 2D-echo o Fractional area change (FAC) as assessed by 2D-echo o Right ventricular (RV) longitudinal strain as assessed by 2D-echo o Tricuspid regurgitation peak gradient (TRPG) as assessed by 2D-echo, Exploratory Pharmacodynamic (PD) Parameters • Change from baseline to EOT in branched-chain amino acids (BCAAs: isoleucine, leucine and valine) and alanine plasma concentrations
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o LVEF as assessed by two-dimensional echocardiography (2D-echo) o Left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo o Left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo, Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o Left atrial volume (LAV) as assessed by 2D-echo o NT-pro-BNP o Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, Pharmacokinetic (PK) Parameters • JTT-861 trough plasma concentrations at Weeks 4, 8 and 12 • JTT-861 plasma concentrations (post-dose) at Weeks 2, 4 and 8, Safety Parameters • Number of subjects with adverse events (AEs), change from baseline in safety laboratory, vital signs and 12-lead electrocardiogram (ECG) parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Efficacy Parameters • Change from baseline to EOT in: o eGFR o Cystatin C o Urine albumin-to-creatinine ratio (ACR) o Hemoglobin A1c (HbA1c) and plasma glucose, Exploratory Efficacy Parameters • Change from baseline to EOT in: o Tricuspid annular plane systolic excursion (TAPSE) as assessed by 2D-echo o Fractional area change (FAC) as assessed by 2D-echo o Right ventricular (RV) longitudinal strain as assessed by 2D-echo o Tricuspid regurgitation peak gradient (TRPG) as assessed by 2D-echo, Exploratory Pharmacodynamic (PD) Parameters • Change from baseline to EOT in branched-chain amino acids (BCAAs: isoleucine, leucine and valine) and alanine plasma concentrations | — |
Countries
Bulgaria, Czechia, Poland, Romania, Spain