ID

20860

Beskrivning

A Pharmacogenomic Study of Candesartan in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00400582

Länk

https://clinicaltrials.gov/show/NCT00400582

Nyckelord

Versioner (1)
  1. 2017-03-22 2017-03-22 -
Uppladdad den

22 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00400582

Engelsk

Eligibility Heart Failure NCT00400582

1 Formulär  
Criteria
Beskrivning

Criteria

1. male or female > or = 18 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. symptomatic chf corresponding to nyha class ii-iv symptoms for at least 4 weeks prior randomization.
Beskrivning

Symptomatic congestive heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1275491
3. lvef < or = 40%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
4. treatment with an optimal and stable dose of ace inhibitor for at least 4 weeks prior to enrolment in the study.
Beskrivning

Angiotensin-Converting Enzyme Inhibitors Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
principal exclusion criteria:
Beskrivning

Exclusion Criteria Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205225
1. treatment with an arb within 8 weeks prior to randomization.
Beskrivning

Angiotensin II receptor antagonist

Datatyp

boolean

Alias
UMLS CUI [1]
C0521942
2. known hypersensitivity to arbs or ace inhibitors.
Beskrivning

Hypersensitivity Angiotensin II receptor antagonist | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003015
3. creatinine clearance < 30 ml/min or serum creatinine > 221
Beskrivning

Creatinine clearance measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0201976
4. current serum potassium > or = 5.0 mmol/l or a history of marked ace inhibitor or arb induced hyperkalemia.
Beskrivning

Serum potassium measurement | Angiotensin-Converting Enzyme Inhibitors Marked | Hyperkalemia Due to Angiotensin II receptor antagonist

Datatyp

boolean

Alias
UMLS CUI [1]
C0302353
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C1706089
UMLS CUI [3,1]
C0020461
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0521942
5. known bilateral renal artery stenosis.
Beskrivning

Bilateral renal artery stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0856760
6. current symptomatic hypotension and/or systolic b.p. < 90 mmhg.
Beskrivning

Hypotension symptomatic | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0863113
UMLS CUI [2]
C0871470
7. decompensated heart failure described as hospitalization or i.v. administration of medication in emergency room or heart failure clinic within 4 weeks
Beskrivning

Decompensated cardiac failure | Hospitalization | Medication administration: intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0581377
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0812149
8. stroke, acute coronary syndrome, pci within the last 4 weeks before randomization.
Beskrivning

Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0948089
UMLS CUI [3]
C1532338
9. connective tissue disease or chronic inflammatory condition
Beskrivning

Connective Tissue Diseases | Chronic inflammatory disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C1290886
10. acute inflammatory process such as an infection or gout attack in the last 2 weeks.
Beskrivning

Inflammatory disorder | Communicable Disease | Gout attack

Datatyp

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0009450
UMLS CUI [3]
C2712871
11. pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Missing

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1705492
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Similar models

Eligibility Heart Failure NCT00400582

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
1. male or female > or = 18 years old.
boolean
C0001779 (UMLS CUI [1])
Symptomatic congestive heart failure New York Heart Association Classification
Item
2. symptomatic chf corresponding to nyha class ii-iv symptoms for at least 4 weeks prior randomization.
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
3. lvef < or = 40%
boolean
C0428772 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors Dose Stable
Item
4. treatment with an optimal and stable dose of ace inhibitor for at least 4 weeks prior to enrolment in the study.
boolean
C0003015 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Exclusion Criteria Primary
Item
principal exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Angiotensin II receptor antagonist
Item
1. treatment with an arb within 8 weeks prior to randomization.
boolean
C0521942 (UMLS CUI [1])
Hypersensitivity Angiotensin II receptor antagonist | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors
Item
2. known hypersensitivity to arbs or ace inhibitors.
boolean
C0020517 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
Creatinine clearance measurement | Creatinine measurement, serum
Item
3. creatinine clearance < 30 ml/min or serum creatinine > 221
boolean
C0373595 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum potassium measurement | Angiotensin-Converting Enzyme Inhibitors Marked | Hyperkalemia Due to Angiotensin II receptor antagonist
Item
4. current serum potassium > or = 5.0 mmol/l or a history of marked ace inhibitor or arb induced hyperkalemia.
boolean
C0302353 (UMLS CUI [1])
C0003015 (UMLS CUI [2,1])
C1706089 (UMLS CUI [2,2])
C0020461 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0521942 (UMLS CUI [3,3])
Bilateral renal artery stenosis
Item
5. known bilateral renal artery stenosis.
boolean
C0856760 (UMLS CUI [1])
Hypotension symptomatic | Systolic Pressure
Item
6. current symptomatic hypotension and/or systolic b.p. < 90 mmhg.
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Decompensated cardiac failure | Hospitalization | Medication administration: intravenous
Item
7. decompensated heart failure described as hospitalization or i.v. administration of medication in emergency room or heart failure clinic within 4 weeks
boolean
C0581377 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0812149 (UMLS CUI [3])
Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention
Item
8. stroke, acute coronary syndrome, pci within the last 4 weeks before randomization.
boolean
C0038454 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Connective Tissue Diseases | Chronic inflammatory disorder
Item
9. connective tissue disease or chronic inflammatory condition
boolean
C0009782 (UMLS CUI [1])
C1290886 (UMLS CUI [2])
Inflammatory disorder | Communicable Disease | Gout attack
Item
10. acute inflammatory process such as an infection or gout attack in the last 2 weeks.
boolean
C1290884 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C2712871 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Missing
Item
11. pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705492 (UMLS CUI [3,3])
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