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ID
20860
Beschrijving
A Pharmacogenomic Study of Candesartan in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00400582
Link
https://clinicaltrials.gov/show/NCT00400582
Trefwoorden
Versies (1)
- 22-03-17 22-03-17 -
Geüploaded op
22 maart 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Heart Failure NCT00400582
Eligibility Heart Failure NCT00400582
- StudyEvent: Eligibility
Similar models
Eligibility Heart Failure NCT00400582
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705492 (UMLS CUI [3,3])