Informed consent
Item
written informed consent must be obtained before any study-specific assessment is performed.
boolean
C0021430 (UMLS CUI [1])
Patient age and sex
Item
male or female ≥20 years of age
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
hospitalized for ahf
Item
hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
boolean
C0264714 (UMLS CUI [1])
C0870668 (UMLS CUI [2])
dyspnea
Item
dyspnea at rest or with minimal exertion
boolean
C0013404 (UMLS CUI [1,1])
C0231807 (UMLS CUI [1,2])
pulmonary congestion
Item
pulmonary congestion on chest x-ray,
boolean
C0242073 (UMLS CUI [1])
bnp ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
Item
bnp ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
sbp ≥125 mmhg at the start and at the end of screening
Item
sbp ≥125 mmhg at the start and at the end of screening
boolean
C0871470 (UMLS CUI [1])
randomized within 16 hours from presentation to the hospital
Item
able to be randomized within 16 hours from presentation to the hospital, including the emergency department
boolean
C1320532 (UMLS CUI [1])
received intravenous (iv) furosemide
Item
received intravenous (iv) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (hf) episode.
boolean
C0354100 (UMLS CUI [1,1])
C1391960 (UMLS CUI [1,2])
impaired renal function
Item
impaired renal function defined as an estimated glomerular filtration rate (egfr) between presentation and randomization of ≥ 25 and≤ 75 ml/min/1.73 m2, calculated using the japanese formula
boolean
C1565489 (UMLS CUI [1])
body weight
Item
with body weight ≥30 kg and ≤160 kg
text
C0005910 (UMLS CUI [1])
dyspnea non cardiac
Item
dyspnea primarily due to non-cardiac causes
boolean
C0013404 (UMLS CUI [1])
temperature >38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment
Item
temperature >38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment
boolean
C0015967 (UMLS CUI [1])
acute coronary syndrome
Item
clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
boolean
C0948089 (UMLS CUI [1])
significant arrhythmias
Item
ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute.
boolean
C0003811 (UMLS CUI [1])
other protocol defined inclusion/exclusion criteria may apply
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C0205394 (UMLS CUI [1])
C1516637 (UMLS CUI [2])