ID

39470

Description

Guiding Evidence Based Therapy Using Biomarker Intensified Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01685840

Link

https://clinicaltrials.gov/show/NCT01685840

Keywords

Versions (1)
  1. 1/14/20 1/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 14, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01685840

English

Eligibility Heart Failure NCT01685840

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
most recent lvef to be ≤ 40% by any method within 12 months of randomization.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
high risk heart failure as defined by the following criteria:
Description

High risk of Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0018801
a heart failure event in the prior 12 months, defined as any one of the following:
Description

Heart failure Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0441471
hf hospitalization
Description

Hospitalization Due to Heart Failure

Data type

boolean

Alias
UMLS CUI [1]
C3898876
treatment in the emergency department (or equivalent) for heart failure
Description

Emergency department Therapy Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0018801
outpatient treatment for heart failure with intravenous diuretics
Description

Outpatient treatment Heart failure | Diuretics Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0002423
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C0012798
UMLS CUI [2,2]
C1522726
nt-probnp greater than 2000 pg/ml or bnp greater than 400 pg/ml at any time during the 30 days prior to randomization
Description

N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C1095989
willing to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
Description

Acute Coronary Syndrome | Myocardial Revascularization

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027056
cardiac resynchronization therapy (crt) within prior 3 months or current plan to implant crt device
Description

Cardiac Resynchronization Therapy | Implantation of CRT-D Planned

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2,1]
C1135480
UMLS CUI [2,2]
C1301732
active myocarditis, hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
Description

Myocarditis | Hypertrophic Cardiomyopathy | Pericarditis | Restrictive cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0031046
UMLS CUI [4]
C0007196
severe stenotic valvular disease
Description

Valvular stenosis Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1883524
UMLS CUI [1,2]
C0205082
anticipated heart transplantation or ventricular assist device within 12 months
Description

Heart Transplantation Anticipated | Artificial Ventricle Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0085842
UMLS CUI [2,2]
C3840775
chronic inotropic therapy
Description

Inotropic agent chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C0205191
complex congenital heart disease
Description

Complex congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0744669
end stage renal disease with renal replacement therapy
Description

Kidney Failure, Chronic | Renal Replacement Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0206074
non cardiac terminal illness with expected survival less than 12 months
Description

Terminal illness | Exception Heart Disease | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
women who are pregnant or planning to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
inability to comply with planned study procedures
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
enrollment or planned enrollment in another clinical trial
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Heart Failure NCT01685840

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction
Item
most recent lvef to be ≤ 40% by any method within 12 months of randomization.
boolean
C0428772 (UMLS CUI [1])
High risk of Heart failure
Item
high risk heart failure as defined by the following criteria:
boolean
C0332167 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Heart failure Event
Item
a heart failure event in the prior 12 months, defined as any one of the following:
boolean
C0018801 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
Hospitalization Due to Heart Failure
Item
hf hospitalization
boolean
C3898876 (UMLS CUI [1])
Emergency department Therapy Heart failure
Item
treatment in the emergency department (or equivalent) for heart failure
boolean
C0562508 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Outpatient treatment Heart failure | Diuretics Intravenous
Item
outpatient treatment for heart failure with intravenous diuretics
boolean
C0002423 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement
Item
nt-probnp greater than 2000 pg/ml or bnp greater than 400 pg/ml at any time during the 30 days prior to randomization
boolean
C3272900 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
Informed Consent
Item
willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome | Myocardial Revascularization
Item
acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
boolean
C0948089 (UMLS CUI [1])
C0027056 (UMLS CUI [2])
Cardiac Resynchronization Therapy | Implantation of CRT-D Planned
Item
cardiac resynchronization therapy (crt) within prior 3 months or current plan to implant crt device
boolean
C1167956 (UMLS CUI [1])
C1135480 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Myocarditis | Hypertrophic Cardiomyopathy | Pericarditis | Restrictive cardiomyopathy
Item
active myocarditis, hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
boolean
C0027059 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0031046 (UMLS CUI [3])
C0007196 (UMLS CUI [4])
Valvular stenosis Severe
Item
severe stenotic valvular disease
boolean
C1883524 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart Transplantation Anticipated | Artificial Ventricle Anticipated
Item
anticipated heart transplantation or ventricular assist device within 12 months
boolean
C0018823 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0085842 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Inotropic agent chronic
Item
chronic inotropic therapy
boolean
C0304509 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Complex congenital heart disease
Item
complex congenital heart disease
boolean
C0744669 (UMLS CUI [1])
Kidney Failure, Chronic | Renal Replacement Therapy
Item
end stage renal disease with renal replacement therapy
boolean
C0022661 (UMLS CUI [1])
C0206074 (UMLS CUI [2])
Terminal illness | Exception Heart Disease | Life Expectancy
Item
non cardiac terminal illness with expected survival less than 12 months
boolean
C0679247 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
women who are pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Protocol Compliance Unable
Item
inability to comply with planned study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial
Item
enrollment or planned enrollment in another clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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