Adult subjects with New York Heart Association (NYHA) Class III congestive heart failure and non-ischemic cardiomyopathy
Conditions
Brief summary
Modified Win Ratio at 52-weeks as defined by hierarchical evaluation of the following assessments in the given order: - Cardiovascular related death (Binary) - NYHA Classification change from baseline (Ordinal) - LVEF change from baseline (Binary, >=5% increase for responders) - six-minute walk test (6MWT) change from baseline (Binary >30m increase for responders), The safety endpoints will be assessed over the 52-week Observation Period as indicated in the Schedule of Activities: - Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) - Observed value and change from baseline in clinical laboratory tests - Observed value and change from baseline in vital signs - Observed value and change from baseline in electrocardiograms (ECGs)
Detailed description
Cardiovascular related death, Functional Status and Hospitalizations at 24 and 52 weeks, Observed value and change from baseline in NYHA Classification, Observed value and change from baseline in LVEF, Observed value and change from baseline in 6MWT, Number of HF hospitalizations, Time to first HF hospitalization, Physiologic Assessments, Observed value and change from baseline in Echocardiographic assessments of: - LVEF (at 4, 12 and 36 weeks) - LV volumes: end systolic and end diastolic volumes - LVEDV and left ventricular end diastolic index (LVEDVI) - LVESV and LVESVI - sphericity index (SpI) - GLS and - degree of mitral regurgitation, Observed value and change from baseline in cardiac biomarker NT-proBNP, Observed value and change from baseline in the KCCQ as assessed by a 15-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and QOL
Interventions
DRUGAB-1002
DRUGAB-1002 Placebo
Sponsors
Askbio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Win Ratio at 52-weeks as defined by hierarchical evaluation of the following assessments in the given order: - Cardiovascular related death (Binary) - NYHA Classification change from baseline (Ordinal) - LVEF change from baseline (Binary, >=5% increase for responders) - six-minute walk test (6MWT) change from baseline (Binary >30m increase for responders), The safety endpoints will be assessed over the 52-week Observation Period as indicated in the Schedule of Activities: - Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) - Observed value and change from baseline in clinical laboratory tests - Observed value and change from baseline in vital signs - Observed value and change from baseline in electrocardiograms (ECGs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular related death, Functional Status and Hospitalizations at 24 and 52 weeks, Observed value and change from baseline in NYHA Classification, Observed value and change from baseline in LVEF, Observed value and change from baseline in 6MWT, Number of HF hospitalizations, Time to first HF hospitalization, Physiologic Assessments, Observed value and change from baseline in Echocardiographic assessments of: - LVEF (at 4, 12 and 36 weeks) - LV volumes: end systolic and end diastolic volumes - LVEDV and left ventricular end diastolic index (LVEDVI) - LVESV and LVESVI - sphericity index (SpI) - GLS and - degree of mitral regurgitation, Observed value and change from baseline in cardiac biomarker NT-proBNP, Observed value and change from baseline in the KCCQ as assessed by a 15-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and QOL | — |
Countries
Austria, Belgium, Bulgaria, Germany, Hungary, Netherlands, Poland, Romania, Spain
Outcome results
None listed