ID

42754

Description

Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02002702

Link

https://clinicaltrials.gov/show/NCT02002702

Keywords

Versions (2)
  1. 12/4/15 12/4/15 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02002702

English

Eligibility Acute Heart Failure NCT02002702

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent must be obtained before any study-specific assessment is performed.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male or female ≥20 years of age
Description

Patient age and sex

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
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:
Description

hospitalized for ahf

Data type

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0870668
dyspnea at rest or with minimal exertion
Description

dyspnea

Data type

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0231807
pulmonary congestion on chest x-ray,
Description

pulmonary congestion

Data type

boolean

Alias
UMLS CUI [1]
C0242073
bnp ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
Description

bnp ≥350 pg/ml or nt-probnp ≥1,400 pg/ml

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
sbp ≥125 mmhg at the start and at the end of screening
Description

sbp ≥125 mmhg at the start and at the end of screening

Data type

boolean

Alias
UMLS CUI [1]
C0871470
able to be randomized within 16 hours from presentation to the hospital, including the emergency department
Description

randomized within 16 hours from presentation to the hospital

Data type

boolean

Alias
UMLS CUI [1]
C1320532
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.
Description

received intravenous (iv) furosemide

Data type

boolean

Alias
UMLS CUI [1,1]
C0354100
UMLS CUI [1,2]
C1391960
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
Description

impaired renal function

Data type

boolean

Alias
UMLS CUI [1]
C1565489
with body weight ≥30 kg and ≤160 kg
Description

body weight

Data type

text

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dyspnea primarily due to non-cardiac causes
Description

dyspnea non cardiac

Data type

boolean

Alias
UMLS CUI [1]
C0013404
temperature >38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment
Description

temperature >38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment

Data type

boolean

Alias
UMLS CUI [1]
C0015967
clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
Description

acute coronary syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
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.
Description

significant arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0003811
other protocol defined inclusion/exclusion criteria may apply.
Description

other protocol defined inclusion/exclusion criteria may apply

Data type

boolean

Alias
UMLS CUI [1]
C0205394
UMLS CUI [2]
C1516637
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Similar models

Eligibility Acute Heart Failure NCT02002702

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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