ID

29471

Beschrijving

Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT00881439

Link

https://clinicaltrials.gov/show/NCT00881439

Trefwoorden

  1. 29-03-18 29-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 maart 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00881439

Eligibility Heart Failure NCT00881439

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha ii-iv heart failure
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
left ventricular ejection fraction < 45%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
stable heart failure medication
Beschrijving

Pharmaceutical Preparations Stable Heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018801
egfr by smdrd formula between 30 and 60 ml/min/1.73m2
Beschrijving

GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C2170215
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to study drug or acei
Beschrijving

Hypersensitivity Investigational New Drugs | Angiotensin-converting-enzyme inhibitor allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0571939
concomitant treatment with both arb and aldosterone receptor antagonist
Beschrijving

Angiotensin II receptor antagonist | Mineralocorticoid Receptor Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C1579268
symptomatic hypotension
Beschrijving

Hypotension symptomatic

Datatype

boolean

Alias
UMLS CUI [1]
C0863113
acute heart failure
Beschrijving

Acute heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0264714
history of stroke, acute coronary syndrome, pci or angioplasty within past 3 months
Beschrijving

Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Angioplasty

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0948089
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0162577
serum potassium > 5.2 mmol/l
Beschrijving

Serum potassium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0302353
right heart failure due to severe pulmonary disease
Beschrijving

Right Heart Failure Due to Lung disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0024115
UMLS CUI [1,4]
C0205082
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Heart Failure NCT00881439

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
nyha ii-iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction < 45%
boolean
C0428772 (UMLS CUI [1])
Pharmaceutical Preparations Stable Heart failure
Item
stable heart failure medication
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
GFR estimation by MDRD
Item
egfr by smdrd formula between 30 and 60 ml/min/1.73m2
boolean
C2170215 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Angiotensin-converting-enzyme inhibitor allergy
Item
known hypersensitivity to study drug or acei
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0571939 (UMLS CUI [2])
Angiotensin II receptor antagonist | Mineralocorticoid Receptor Antagonists
Item
concomitant treatment with both arb and aldosterone receptor antagonist
boolean
C0521942 (UMLS CUI [1])
C1579268 (UMLS CUI [2])
Hypotension symptomatic
Item
symptomatic hypotension
boolean
C0863113 (UMLS CUI [1])
Acute heart failure
Item
acute heart failure
boolean
C0264714 (UMLS CUI [1])
Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Angioplasty
Item
history of stroke, acute coronary syndrome, pci or angioplasty within past 3 months
boolean
C0038454 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0162577 (UMLS CUI [4])
Serum potassium measurement
Item
serum potassium > 5.2 mmol/l
boolean
C0302353 (UMLS CUI [1])
Right Heart Failure Due to Lung disease Severe
Item
right heart failure due to severe pulmonary disease
boolean
C0235527 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0024115 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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