Acute Heart Failure
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Actively being hospitalized for acute decompensated heart failure At least 1 administration of IV diuretic for the current episode Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic Have history of heart failure and a left ventricular ejection fraction (LVEF) 40% or less
Exclusion criteria
Exclusion criteria: Systolic blood pressure less than105mm Hg or more than 160mm Hg or heart rate less than 50 or more than 130 bpm Have an active infection requiring IV anti-microbial treatment Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Clinically relevant hypotension [ Time Frame: Hour 0 to 6 hours after the end of study drug infusion ] 1.Clinically relevant hypotension [ Time Frame: Hour 0 to 6 hours after the end of study drug infusion ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety exploratory pharmacokinetics pharmacodynamics pharmacogenomics 1.Change in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) [ Time Frame: From baseline to hour 24, 48, 72, 120 or discharge (whichever comes first), and at day 32 ] 2.Change in patient-reported resting dyspnea, as measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) [ Time Frame: From baseline to hour 6, 12, 24, 48 and 72 ] 1.Change in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) [ Time Frame: From baseline to hour 24, 48, 72, 120 or discharge (whichever comes first), and at day 32 ] 2.Change in patient-reported resting dyspnea, as measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) [ Time Frame: From baseline to hour 6, 12, 24, 48 and 72 ] | — |
Countries
Europe, Japan, North America, South America
Outcome results
None listed