ID

16848

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00652652

Palabras clave

Versiones (1)
  1. 10/8/16 10/8/16 -
Subido en

10 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00652652

Inglés

Eligibility Congestive Heart Failure NCT00652652

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Symptomatic congestive heart failure chronic | New York Heart Association Classification

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

Serum potassium measurement

Tipo de datos

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
Descripción

Furosemide Daily Oral chronic Patient need for

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Disease Unstable Clinical | Diuretic therapy Discontinuation At risk patient safety

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Systolic Pressure

Tipo de datos

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
Descripción

Myocardial Infarction | Angina, Unstable | Myocardial Ischemia Evidence Clinical

Tipo de datos

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
Descripción

Percutaneous Coronary Intervention | Cardiac Surgery procedures

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

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

Allograft heart | Allograft kidney

Tipo de datos

boolean

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

Eligibility Congestive Heart Failure NCT00652652

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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