ID

42764

Descrição

Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02151383

Link

https://clinicaltrials.gov/show/NCT02151383

Palavras-chave

Versões (2)
  1. 07/12/2015 07/12/2015 -
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Acute Heart Failure DRKS00008447 NCT02151383

Inglês

Eligibility Acute Heart Failure NCT02151383

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
body weight ≥2.5 kg to ≤120 kg
Descrição

body weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
hospitalization in an intensive care unit or step-down unit with the following:
Descrição

hospitalization in an intensive care unit or step-down unit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0021708
signs and symptoms of acute heart failure of any etiology
Descrição

acute heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0264714
stable dose of vasoactive and/or inotropic drugs
Descrição

stable dose of vasoactive and/or inotropic drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0597639
UMLS CUI [2]
C0304509
for non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction <50 percent or fractional shortening <28 percent)
Descrição

echocardiographic evidence of reduced ventricular function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3839346
systolic blood pressure (sbp) ≥25th percentile sbp for age and gender.
Descrição

systolic blood pressure (sbp) ≥25th percentile sbp for age and gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction
Descrição

moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155572
UMLS CUI [2]
C3164271
single ventricle physiology
Descrição

single ventricle physiology

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274516
fixed pulmonary hypertension
Descrição

fixed pulmonary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020542
blood lactate levels >5 mmol/l at screening
Descrição

blood lactate levels

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1273449
birth < 36 weeks post-conceptual age (for patients <1year old)
Descrição

birth < 36 weeks post-conceptual age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3827345
UMLS CUI [2]
C2599577
confirmed or clinically suspected systemic infection or severe localized infection
Descrição

confirmed or clinically suspected systemic infection or severe localized infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
dyspnea or acute lung injury primarily due to non-cardiac causes
Descrição

dyspnea or acute lung injury primarily due to non-cardiac causes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013404
UMLS CUI [2]
C0242488
patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
Descrição

patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0206074
high use of inotropic and/or vasoactive agents at screening
Descrição

high use of inotropic and/or vasoactive agents at screening

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304509
UMLS CUI [2]
C0597639
UMLS CUI [3]
C0087111
electrocardiographic abnormalities
Descrição

ecg abnormality

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522055
solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection
Descrição

solid organ transplant recipient or severe organ rejection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2]
C0345468
other protocol defined inclusion/exclusion criteria may apply.
Descrição

other protocol defined inclusion/exclusion criteria may apply

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205394
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Similar models

Eligibility Acute Heart Failure NCT02151383

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
body weight
Item
body weight ≥2.5 kg to ≤120 kg
boolean
C0005910 (UMLS CUI [1])
hospitalization in an intensive care unit or step-down unit
Item
hospitalization in an intensive care unit or step-down unit with the following:
boolean
C0019993 (UMLS CUI [1])
C0021708 (UMLS CUI [2])
acute heart failure
Item
signs and symptoms of acute heart failure of any etiology
boolean
C0264714 (UMLS CUI [1])
stable dose of vasoactive and/or inotropic drugs
Item
stable dose of vasoactive and/or inotropic drugs
boolean
C0597639 (UMLS CUI [1])
C0304509 (UMLS CUI [2])
echocardiographic evidence of reduced ventricular function
Item
for non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction <50 percent or fractional shortening <28 percent)
boolean
C3839346 (UMLS CUI [1])
systolic blood pressure (sbp) ≥25th percentile sbp for age and gender
Item
systolic blood pressure (sbp) ≥25th percentile sbp for age and gender.
boolean
C0871470 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction
Item
moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction
boolean
C0155572 (UMLS CUI [1])
C3164271 (UMLS CUI [2])
single ventricle physiology
Item
single ventricle physiology
boolean
C3274516 (UMLS CUI [1])
fixed pulmonary hypertension
Item
fixed pulmonary hypertension
boolean
C0020542 (UMLS CUI [1])
blood lactate levels
Item
blood lactate levels >5 mmol/l at screening
boolean
C1273449 (UMLS CUI [1])
birth < 36 weeks post-conceptual age
Item
birth < 36 weeks post-conceptual age (for patients <1year old)
boolean
C3827345 (UMLS CUI [1])
C2599577 (UMLS CUI [2])
confirmed or clinically suspected systemic infection or severe localized infection
Item
confirmed or clinically suspected systemic infection or severe localized infection
boolean
C0009450 (UMLS CUI [1])
dyspnea or acute lung injury primarily due to non-cardiac causes
Item
dyspnea or acute lung injury primarily due to non-cardiac causes
boolean
C0013404 (UMLS CUI [1])
C0242488 (UMLS CUI [2])
patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
Item
patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
boolean
C0035078 (UMLS CUI [1])
C0206074 (UMLS CUI [2])
high use of inotropic and/or vasoactive agents at screening
Item
high use of inotropic and/or vasoactive agents at screening
boolean
C0304509 (UMLS CUI [1])
C0597639 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
ecg abnormality
Item
electrocardiographic abnormalities
boolean
C0522055 (UMLS CUI [1])
solid organ transplant recipient or severe organ rejection
Item
solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection
boolean
C0730400 (UMLS CUI [1])
C0345468 (UMLS CUI [2])
other protocol defined inclusion/exclusion criteria may apply
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C0205394 (UMLS CUI [1])
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