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ID

16848

Beskrivning

Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS; ODM derived from: https://clinicaltrials.gov/show/NCT00652652

Länk

https://clinicaltrials.gov/show/NCT00652652

Nyckelord

  1. 2016-08-10 2016-08-10 -
Uppladdad den

10 augusti 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Congestive Heart Failure NCT00652652

    Eligibility Congestive Heart Failure NCT00652652

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    chronic symptomatic nyha class ii or iii chf for at least 90 days before the study
    Beskrivning

    Symptomatic congestive heart failure chronic | New York Heart Association Classification

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0742758
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2]
    C1275491
    left ventricular systolic dysfunction as evidenced by left ventricular ejection fraction < 40%, measured using contrast or radionuclide ventriculography or by echocardiography, within 180 days of the study start
    Beskrivning

    Left ventricular systolic dysfunction Evidence of | Left ventricular ejection fraction | Cardiac ventriculography | Radionuclide Ventriculography | Echocardiography

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1277187
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2]
    C0428772
    UMLS CUI [3]
    C0596683
    UMLS CUI [4]
    C0034610
    UMLS CUI [5]
    C0013516
    serum potassium > 3.5 meq/l.
    Beskrivning

    Serum potassium measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0302353
    chronic oral daily requirement of 80-240 mg of furosemide for at least 7 days before the study start
    Beskrivning

    Furosemide Daily Oral chronic Patient need for

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0016860
    UMLS CUI [1,2]
    C0332173
    UMLS CUI [1,3]
    C1527415
    UMLS CUI [1,4]
    C0205191
    UMLS CUI [1,5]
    C0686904
    receiving a stable medical regimen for chf for at least 60 days before the study start, including angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blockers (arbs), and/or beta-blockers.
    Beskrivning

    Congestive heart failure Therapeutic procedure Stable | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205360
    UMLS CUI [2]
    C0003015
    UMLS CUI [3]
    C0521942
    UMLS CUI [4]
    C0001645
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    clinical instability such that withholding diuretic therapy would be unsafe
    Beskrivning

    Disease Unstable Clinical | Diuretic therapy Discontinuation At risk patient safety

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [1,3]
    C0205210
    UMLS CUI [2,1]
    C0948575
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [2,3]
    C1444641
    UMLS CUI [2,4]
    C1113679
    significant renal impairment (e.g., creatinine clearance < 45 ml/min by the cockcroft-gault formula), or changing renal function during the 7 days before study start, or intrinsic renal disease
    Beskrivning

    Renal Insufficiency Significant | Estimation of creatinine clearance by Cockcroft-Gault formula | Renal alteration | RENAL FAILURE INTRINSIC

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1565489
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2]
    C2711451
    UMLS CUI [3]
    C0184571
    UMLS CUI [4]
    C0748306
    systolic blood pressure (sbp) consistently < 90 mm hg
    Beskrivning

    Systolic Pressure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    myocardial infarction within 90 days of study start, unstable angina within 14 days of study start, or any clinical evidence of active myocardial ischemia
    Beskrivning

    Myocardial Infarction | Angina, Unstable | Myocardial Ischemia Evidence Clinical

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0002965
    UMLS CUI [3,1]
    C0151744
    UMLS CUI [3,2]
    C3887511
    UMLS CUI [3,3]
    C0205210
    percutaneous coronary intervention or cardiac surgery within 90 days of study start
    Beskrivning

    Percutaneous Coronary Intervention | Cardiac Surgery procedures

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1532338
    UMLS CUI [2]
    C0018821
    restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, other conditions in which cardiac output was dependent on venous return, or for subjects expected to have low filling pressures
    Beskrivning

    Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007196
    UMLS CUI [2]
    C0007194
    UMLS CUI [3]
    C0031048
    UMLS CUI [4]
    C0007177
    prior cardiac or renal allografts
    Beskrivning

    Allograft heart | Allograft kidney

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0564471
    UMLS CUI [2]
    C0564454

    Similar models

    Eligibility Congestive Heart Failure NCT00652652

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Symptomatic congestive heart failure chronic | New York Heart Association Classification
    Item
    chronic symptomatic nyha class ii or iii chf for at least 90 days before the study
    boolean
    C0742758 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [2])
    Left ventricular systolic dysfunction Evidence of | Left ventricular ejection fraction | Cardiac ventriculography | Radionuclide Ventriculography | Echocardiography
    Item
    left ventricular systolic dysfunction as evidenced by left ventricular ejection fraction < 40%, measured using contrast or radionuclide ventriculography or by echocardiography, within 180 days of the study start
    boolean
    C1277187 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [2])
    C0596683 (UMLS CUI [3])
    C0034610 (UMLS CUI [4])
    C0013516 (UMLS CUI [5])
    Serum potassium measurement
    Item
    serum potassium > 3.5 meq/l.
    boolean
    C0302353 (UMLS CUI [1])
    Furosemide Daily Oral chronic Patient need for
    Item
    chronic oral daily requirement of 80-240 mg of furosemide for at least 7 days before the study start
    boolean
    C0016860 (UMLS CUI [1,1])
    C0332173 (UMLS CUI [1,2])
    C1527415 (UMLS CUI [1,3])
    C0205191 (UMLS CUI [1,4])
    C0686904 (UMLS CUI [1,5])
    Congestive heart failure Therapeutic procedure Stable | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists
    Item
    receiving a stable medical regimen for chf for at least 60 days before the study start, including angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blockers (arbs), and/or beta-blockers.
    boolean
    C0018802 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    C0003015 (UMLS CUI [2])
    C0521942 (UMLS CUI [3])
    C0001645 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Disease Unstable Clinical | Diuretic therapy Discontinuation At risk patient safety
    Item
    clinical instability such that withholding diuretic therapy would be unsafe
    boolean
    C0012634 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C0948575 (UMLS CUI [2,1])
    C1444662 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    C1113679 (UMLS CUI [2,4])
    Renal Insufficiency Significant | Estimation of creatinine clearance by Cockcroft-Gault formula | Renal alteration | RENAL FAILURE INTRINSIC
    Item
    significant renal impairment (e.g., creatinine clearance < 45 ml/min by the cockcroft-gault formula), or changing renal function during the 7 days before study start, or intrinsic renal disease
    boolean
    C1565489 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C2711451 (UMLS CUI [2])
    C0184571 (UMLS CUI [3])
    C0748306 (UMLS CUI [4])
    Systolic Pressure
    Item
    systolic blood pressure (sbp) consistently < 90 mm hg
    boolean
    C0871470 (UMLS CUI [1])
    Myocardial Infarction | Angina, Unstable | Myocardial Ischemia Evidence Clinical
    Item
    myocardial infarction within 90 days of study start, unstable angina within 14 days of study start, or any clinical evidence of active myocardial ischemia
    boolean
    C0027051 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    C0151744 (UMLS CUI [3,1])
    C3887511 (UMLS CUI [3,2])
    C0205210 (UMLS CUI [3,3])
    Percutaneous Coronary Intervention | Cardiac Surgery procedures
    Item
    percutaneous coronary intervention or cardiac surgery within 90 days of study start
    boolean
    C1532338 (UMLS CUI [1])
    C0018821 (UMLS CUI [2])
    Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade
    Item
    restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, other conditions in which cardiac output was dependent on venous return, or for subjects expected to have low filling pressures
    boolean
    C0007196 (UMLS CUI [1])
    C0007194 (UMLS CUI [2])
    C0031048 (UMLS CUI [3])
    C0007177 (UMLS CUI [4])
    Allograft heart | Allograft kidney
    Item
    prior cardiac or renal allografts
    boolean
    C0564471 (UMLS CUI [1])
    C0564454 (UMLS CUI [2])

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