ID

17401

Description

Nesiritide in Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00145873

Link

https://clinicaltrials.gov/show/NCT00145873

Keywords

Versions (2)
  1. 9/12/16 9/12/16 -
  2. 9/12/16 9/12/16 -
Uploaded on

September 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00145873

English

Eligibility Heart Failure NCT00145873

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
candidates for enrollment in this clinical trial are limited to adult patients (age>21) diagnosed with chronic heart failure > one year who are managed by heart failure specialists at the university of chicago. patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. study patients are characterized as "high risk" by fulfilling one or more of the following criteria:
Description

Adult | Age | Chronic heart failure disease length | High risk

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0264716
UMLS CUI [3,2]
C0872146
UMLS CUI [4]
C0332167
1. refractory class iii or iv heart failure despite optimal medical therapy by a heart failure specialist: angiotensin converting enzyme inhibitors (acei), angiotensin receptor blockers (arb), beta-adrenergic blockers (bb), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (ccb).
Description

Refractory heart failure | New York Heart Association Classification | Therapeutic procedure Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Spironolactone | Digoxin | Diuretics | Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1]
C1281998
UMLS CUI [2]
C1275491
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
UMLS CUI [4]
C0003015
UMLS CUI [5]
C0521942
UMLS CUI [6]
C0001645
UMLS CUI [7]
C0037982
UMLS CUI [8]
C0012265
UMLS CUI [9]
C0012798
UMLS CUI [10]
C0006684
2. frequent hospitalizations or er visits (>1/month on average).
Description

frequent hospitalization | frequent emergency room visits

Data type

boolean

Alias
UMLS CUI [1]
C2008809
UMLS CUI [2]
C2008803
additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous iv infusion therapy with the assistance of home care nursing and the study coordinator.
Description

Informed Consent | Home Infusion Therapy Intravenous Continuous chronic | nursing home care

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0242945
UMLS CUI [2,2]
C0021440
UMLS CUI [2,3]
C0549178
UMLS CUI [2,4]
C0205191
UMLS CUI [3]
C0260062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nesiritide infusion >24 hours in the previous 30 days.
Description

infusion of nesiritide

Data type

boolean

Alias
UMLS CUI [1]
C1135444
2. stable chronic heart failure or nyha class i or ii.
Description

Chronic heart failure Stable | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C1275491
3. aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
Description

Aortic Valve Stenosis Degrees of severity | Echocardiography | Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0441982
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0007430
4. hypertrophic cardiomyopathy with an outflow tract gradient.
Description

Hypertrophic Cardiomyopathy | Outflow tract of left ventricle Gradient

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C0225912
UMLS CUI [2,2]
C0812409
5. isolated right heart failure (cor pulmonale).
Description

Right Heart Failure Isolated | Cor pulmonale

Data type

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0205409
UMLS CUI [2]
C0034072
6. unstable coronary syndrome or myocardial infarction< 3 months prior to enrollment.
Description

Coronary Syndrome Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0027051
7. chronic hypotension with systolic blood pressure < 80 mmhg.
Description

Chronic hypotension | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0155800
UMLS CUI [2]
C0871470
8. terminal noncardiovascular illness with life expectancy <6 months. moribund patients will not be considered for enrollment.
Description

Cardiovascular Disease End-stage | Life Expectancy | Moribund

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205088
UMLS CUI [2]
C0023671
UMLS CUI [3]
C0424547
9. active substance abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. inadequate social support.
Description

Lack Of Social Support

Data type

boolean

Alias
UMLS CUI [1]
C2364105
11. contraindication to long term iv access.
Description

Medical contraindication Intravenous Access Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3650989
UMLS CUI [1,3]
C0443252
12. pregnant or lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Heart Failure NCT00145873

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Chronic heart failure disease length | High risk
Item
candidates for enrollment in this clinical trial are limited to adult patients (age>21) diagnosed with chronic heart failure > one year who are managed by heart failure specialists at the university of chicago. patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. study patients are characterized as "high risk" by fulfilling one or more of the following criteria:
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0264716 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0332167 (UMLS CUI [4])
Refractory heart failure | New York Heart Association Classification | Therapeutic procedure Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Spironolactone | Digoxin | Diuretics | Calcium Channel Blockers
Item
1. refractory class iii or iv heart failure despite optimal medical therapy by a heart failure specialist: angiotensin converting enzyme inhibitors (acei), angiotensin receptor blockers (arb), beta-adrenergic blockers (bb), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (ccb).
boolean
C1281998 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
C0003015 (UMLS CUI [4])
C0521942 (UMLS CUI [5])
C0001645 (UMLS CUI [6])
C0037982 (UMLS CUI [7])
C0012265 (UMLS CUI [8])
C0012798 (UMLS CUI [9])
C0006684 (UMLS CUI [10])
frequent hospitalization | frequent emergency room visits
Item
2. frequent hospitalizations or er visits (>1/month on average).
boolean
C2008809 (UMLS CUI [1])
C2008803 (UMLS CUI [2])
Informed Consent | Home Infusion Therapy Intravenous Continuous chronic | nursing home care
Item
additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous iv infusion therapy with the assistance of home care nursing and the study coordinator.
boolean
C0021430 (UMLS CUI [1])
C0242945 (UMLS CUI [2,1])
C0021440 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C0260062 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
infusion of nesiritide
Item
1. nesiritide infusion >24 hours in the previous 30 days.
boolean
C1135444 (UMLS CUI [1])
Chronic heart failure Stable | New York Heart Association Classification
Item
2. stable chronic heart failure or nyha class i or ii.
boolean
C0264716 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
Aortic Valve Stenosis Degrees of severity | Echocardiography | Catheterization
Item
3. aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
boolean
C0003507 (UMLS CUI [1,1])
C0441982 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
C0007430 (UMLS CUI [3])
Hypertrophic Cardiomyopathy | Outflow tract of left ventricle Gradient
Item
4. hypertrophic cardiomyopathy with an outflow tract gradient.
boolean
C0007194 (UMLS CUI [1])
C0225912 (UMLS CUI [2,1])
C0812409 (UMLS CUI [2,2])
Right Heart Failure Isolated | Cor pulmonale
Item
5. isolated right heart failure (cor pulmonale).
boolean
C0235527 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
C0034072 (UMLS CUI [2])
Coronary Syndrome Unstable | Myocardial Infarction
Item
6. unstable coronary syndrome or myocardial infarction< 3 months prior to enrollment.
boolean
C0948089 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Chronic hypotension | Systolic Pressure
Item
7. chronic hypotension with systolic blood pressure < 80 mmhg.
boolean
C0155800 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Cardiovascular Disease End-stage | Life Expectancy | Moribund
Item
8. terminal noncardiovascular illness with life expectancy <6 months. moribund patients will not be considered for enrollment.
boolean
C0007222 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
C0424547 (UMLS CUI [3])
Substance Use Disorders
Item
9. active substance abuse.
boolean
C0038586 (UMLS CUI [1])
Lack Of Social Support
Item
10. inadequate social support.
boolean
C2364105 (UMLS CUI [1])
Medical contraindication Intravenous Access Long-term
Item
11. contraindication to long term iv access.
boolean
C1301624 (UMLS CUI [1,1])
C3650989 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
12. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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