ID

42754

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02002702

Nyckelord

Versioner (2)
  1. 2015-12-04 2015-12-04 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Acute Heart Failure NCT02002702

Engelsk

Eligibility Acute Heart Failure NCT02002702

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed consent

Datatyp

boolean

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

Patient age and sex

Datatyp

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:
Beskrivning

hospitalized for ahf

Datatyp

boolean

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

dyspnea

Datatyp

boolean

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

pulmonary congestion

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

randomized within 16 hours from presentation to the hospital

Datatyp

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.
Beskrivning

received intravenous (iv) furosemide

Datatyp

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
Beskrivning

impaired renal function

Datatyp

boolean

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

body weight

Datatyp

text

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

dyspnea non cardiac

Datatyp

boolean

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

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

Datatyp

boolean

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

acute coronary syndrome

Datatyp

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.
Beskrivning

significant arrhythmias

Datatyp

boolean

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

other protocol defined inclusion/exclusion criteria may apply

Datatyp

boolean

Alias
UMLS CUI [1]
C0205394
UMLS CUI [2]
C1516637
Tillbaka till toppen

Similar models

Eligibility Acute Heart Failure NCT02002702

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial