ID

17422

Description

Nesiritide and Vo2 Max in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00240084

Link

https://clinicaltrials.gov/show/NCT00240084

Keywords

Versions (1)
  1. 9/13/16 9/13/16 -
Uploaded on

September 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00240084

English

Eligibility Heart Failure NCT00240084

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18-65 with nyha class ii or iii heart failure
Description

Age | Heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018801
UMLS CUI [3]
C1275491
referred to strong memorial hospital for consideration of heart transplant
Description

Hospital Referral consideration Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0019982
UMLS CUI [1,2]
C0518609
UMLS CUI [1,3]
C0018823
male or female and infertile or using effective contraception with negative pregnancy test
Description

Gender Infertility | Gender Contraceptive methods | Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0021359
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0427780
capable of iv access
Description

venous access Capability

Data type

boolean

Alias
UMLS CUI [1,1]
C0750164
UMLS CUI [1,2]
C2698977
able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
Description

Bicycle Ergometry Test Maximal Ability | Accepting MOUTHPIECE | Accepting Nose Clips

Data type

boolean

Alias
UMLS CUI [1,1]
C0005376
UMLS CUI [1,2]
C0205289
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C1272684
UMLS CUI [2,2]
C0490111
UMLS CUI [3,1]
C1272684
UMLS CUI [3,2]
C0179986
fully understands and has signed informed consent form before study begins
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
endogenous bnp level of at least 100 pg/ml
Description

Brain natriuretic peptide measurement Endogenous

Data type

boolean

Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C0205227
current smokers smoking < 3 cigarettes / day. smoking is not permitted within the hospital, ergo subjects would not be permitted to smoke during study participation.
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nyha class i or iv heart failure
Description

Heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of the study
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
ef > 40%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
evidence of primary lung disease
Description

Lung disease Primary Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0332120
hypersensitivity to nesiritide or any of its' components
Description

Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0054015
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0054015
UMLS CUI [2,3]
C1705248
current smokers as defined by > 3 cigarettes / day
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
stroke within 3 months, myocardial infarction within 2 months, or any evidence of active myocardial ischemia
Description

Cerebrovascular accident | Myocardial Infarction | Myocardial Ischemia Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0332120
unwillingness ir inability to remain in the hospital overnight
Description

Hospital Stay Overnight Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0558080
clinical condition or laboratory abnormality which may increase risks associated with participation or interfere with result interpretation
Description

medical condition Study Subject Participation Status Limited | LABORATORY ABNORMALITIES Study Subject Participation Status Limited | medical condition Interferes with research results | LABORATORY ABNORMALITIES Interferes with research results

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C1853129
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
any condition which would preclude heart transplantation.
Description

Condition Exclusion Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0018823
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Similar models

Eligibility Heart Failure NCT00240084

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Heart failure | New York Heart Association Classification
Item
aged 18-65 with nyha class ii or iii heart failure
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C1275491 (UMLS CUI [3])
Hospital Referral consideration Heart Transplantation
Item
referred to strong memorial hospital for consideration of heart transplant
boolean
C0019982 (UMLS CUI [1,1])
C0518609 (UMLS CUI [1,2])
C0018823 (UMLS CUI [1,3])
Gender Infertility | Gender Contraceptive methods | Pregnancy test negative
Item
male or female and infertile or using effective contraception with negative pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0427780 (UMLS CUI [3])
venous access Capability
Item
capable of iv access
boolean
C0750164 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
Bicycle Ergometry Test Maximal Ability | Accepting MOUTHPIECE | Accepting Nose Clips
Item
able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
boolean
C0005376 (UMLS CUI [1,1])
C0205289 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C1272684 (UMLS CUI [2,1])
C0490111 (UMLS CUI [2,2])
C1272684 (UMLS CUI [3,1])
C0179986 (UMLS CUI [3,2])
Informed Consent
Item
fully understands and has signed informed consent form before study begins
boolean
C0021430 (UMLS CUI [1])
Brain natriuretic peptide measurement Endogenous
Item
endogenous bnp level of at least 100 pg/ml
boolean
C1095989 (UMLS CUI [1,1])
C0205227 (UMLS CUI [1,2])
Tobacco use Number of cigarettes per day
Item
current smokers smoking < 3 cigarettes / day. smoking is not permitted within the hospital, ergo subjects would not be permitted to smoke during study participation.
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
nyha class i or iv heart failure
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of the study
boolean
C0373595 (UMLS CUI [1])
Cardiac ejection fraction
Item
ef > 40%
boolean
C0232174 (UMLS CUI [1])
Lung disease Primary Evidence of
Item
evidence of primary lung disease
boolean
C0024115 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Component
Item
hypersensitivity to nesiritide or any of its' components
boolean
C0020517 (UMLS CUI [1,1])
C0054015 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0054015 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Tobacco use Number of cigarettes per day
Item
current smokers as defined by > 3 cigarettes / day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Cerebrovascular accident | Myocardial Infarction | Myocardial Ischemia Evidence of
Item
stroke within 3 months, myocardial infarction within 2 months, or any evidence of active myocardial ischemia
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0151744 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
Hospital Stay Overnight Unwilling
Item
unwillingness ir inability to remain in the hospital overnight
boolean
C3489408 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
medical condition Study Subject Participation Status Limited | LABORATORY ABNORMALITIES Study Subject Participation Status Limited | medical condition Interferes with research results | LABORATORY ABNORMALITIES Interferes with research results
Item
clinical condition or laboratory abnormality which may increase risks associated with participation or interfere with result interpretation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1853129 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C1853129 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Condition Exclusion Heart Transplantation
Item
any condition which would preclude heart transplantation.
boolean
C0348080 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0018823 (UMLS CUI [1,3])
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