ID

17127

Description

Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00160134

Link

https://clinicaltrials.gov/show/NCT00160134

Keywords

  1. 8/25/16 8/25/16 -
Uploaded on

August 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Congestive Heart Failure NCT00160134

Eligibility Congestive Heart Failure NCT00160134

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chronic, symptomatic, mild to severe (nyha class ii-iv) chf for at least three months requiring treatment with diuretics and with documented systolic dysfunction
Description

chronic, symptomatic, mild to severe (nyha class ii-iv) chf for at least three months requiring treatment with diuretics and with documented systolic dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0264722
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0749225
on stable doses of their individually optimized medication regimen for at least one week prior to enrollment
Description

stable doses of medication regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
required hospitalization (for cardiovascular disease) or adjustment of background medications for chf
Description

required hospitalization (for cardiovascular disease) or adjustment of background medications for chf

Data type

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0580105
orthostatic hypotension or symptomatic orthostasis
Description

orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2,1]
C0149746
UMLS CUI [2,2]
C0231220
sitting systolic or diastolic blood pressure < 90 mmhg
Description

blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
2nd or 3rd degree atrio-ventricular block or sick sinus syndrome
Description

atrioventricular block or sick sinus syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0004245
UMLS CUI [2]
C0037052
heart rate of < 50 or > 110 bpm on the ecg
Description

heart rate

Data type

boolean

Alias
UMLS CUI [1]
C0018810
transplanted heart
Description

transplanted heart

Data type

boolean

Alias
UMLS CUI [1]
C1279380
heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease
Description

heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C2064629
UMLS CUI [3]
C0340418
UMLS CUI [4]
C0265122
UMLS CUI [5]
C0034072
UMLS CUI [6]
C0152021
hemodynamically significant left ventricular outflow tract obstruction
Description

hemodynamically significant left ventricular outflow tract obstruction

Data type

boolean

Alias
UMLS CUI [1,1]
C0344917
UMLS CUI [1,2]
C0948268

Similar models

Eligibility Congestive Heart Failure NCT00160134

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
chronic, symptomatic, mild to severe (nyha class ii-iv) chf for at least three months requiring treatment with diuretics and with documented systolic dysfunction
Item
history of chronic, symptomatic, mild to severe (nyha class ii-iv) chf for at least three months requiring treatment with diuretics and with documented systolic dysfunction
boolean
C0264722 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0012798 (UMLS CUI [2])
C0749225 (UMLS CUI [3])
stable doses of medication regimen
Item
on stable doses of their individually optimized medication regimen for at least one week prior to enrollment
boolean
C0237125 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
required hospitalization (for cardiovascular disease) or adjustment of background medications for chf
Item
required hospitalization (for cardiovascular disease) or adjustment of background medications for chf
boolean
C0019993 (UMLS CUI [1])
C0580105 (UMLS CUI [2])
orthostatic hypotension
Item
orthostatic hypotension or symptomatic orthostasis
boolean
C0020651 (UMLS CUI [1])
C0149746 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
blood pressure
Item
sitting systolic or diastolic blood pressure < 90 mmhg
boolean
C0005823 (UMLS CUI [1])
atrioventricular block or sick sinus syndrome
Item
2nd or 3rd degree atrio-ventricular block or sick sinus syndrome
boolean
C0004245 (UMLS CUI [1])
C0037052 (UMLS CUI [2])
heart rate
Item
heart rate of < 50 or > 110 bpm on the ecg
boolean
C0018810 (UMLS CUI [1])
transplanted heart
Item
transplanted heart
boolean
C1279380 (UMLS CUI [1])
heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease
Item
heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease
boolean
C0018801 (UMLS CUI [1])
C2064629 (UMLS CUI [2])
C0340418 (UMLS CUI [3])
C0265122 (UMLS CUI [4])
C0034072 (UMLS CUI [5])
C0152021 (UMLS CUI [6])
hemodynamically significant left ventricular outflow tract obstruction
Item
hemodynamically significant left ventricular outflow tract obstruction
boolean
C0344917 (UMLS CUI [1,1])
C0948268 (UMLS CUI [1,2])

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