ID

15192

Description

Genomic Response Analysis of Heart Failure Therapy in African Americans; ODM derived from: https://clinicaltrials.gov/show/NCT02305095

Link

https://clinicaltrials.gov/show/NCT02305095

Keywords

Versions (1)
  1. 5/22/16 5/22/16 -
Uploaded on

May 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02305095

English

Eligibility Heart Failure NCT02305095

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history of heart failure with an lvef (less than or equal to) < 0.35 for at least 6 months or an lvef < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area or more than 6.5 cm on the basis of echocardiography).
Description

Heart failure | Left ventricular ejection fraction | Diastolic left ventricular internal diameter End diastole | Body Surface Area | Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C0919652
UMLS CUI [3,2]
C1562146
UMLS CUI [4]
C0005902
UMLS CUI [5]
C0013516
new york heart association (nyha) class ii-iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
background heart failure therapy that includes angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blockers (arbs), and beta blockers (bbs) for at least 3 months (or documentation of intolerance to acei/arbs and bbs)
Description

Therapeutic procedure Background Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | intolerance to Angiotensin-Converting Enzyme Inhibitors | intolerance to Angiotensin II receptor antagonist | intolerance to Adrenergic beta-Antagonists ,

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1706907
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0001645
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0003015
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0521942
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0001645
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no history of intolerance to either nitrates or hydralazine
Description

intolerance to Nitrates | intolerance to Hydralazine

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0028125
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0020223
no treatment with the combination of hydralazine and nitrates for the previous 3 months
Description

Combination Drug Therapy Hydralazine Nitrates

Data type

boolean

Alias
UMLS CUI [1,1]
C0013218
UMLS CUI [1,2]
C0020223
UMLS CUI [1,3]
C0028125
no revascularization or myocardial infarction within last 90 days
Description

Revascularization | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0581603
UMLS CUI [2]
C0027051
can not be enrolled for at least 90 days after receiving cardiac resynchronization therapy (crt) and must have an lvef (less than or equal to) < 0.35 at least 3 months after crt.
Description

Cardiac Resynchronization Therapy | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C0428772
presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension.
Description

Heart valve disease | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | myocarditis; active | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0238294
UMLS CUI [5]
C1868885
women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy.
Description

Pregnancy | Pregnancy, Planned | Pregnancy Preventing Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0558080
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Similar models

Eligibility Heart Failure NCT02305095

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Heart failure | Left ventricular ejection fraction | Diastolic left ventricular internal diameter End diastole | Body Surface Area | Echocardiography
Item
history of heart failure with an lvef (less than or equal to) < 0.35 for at least 6 months or an lvef < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area or more than 6.5 cm on the basis of echocardiography).
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0919652 (UMLS CUI [3,1])
C1562146 (UMLS CUI [3,2])
C0005902 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
New York Heart Association Classification
Item
new york heart association (nyha) class ii-iv
boolean
C1275491 (UMLS CUI [1])
Therapeutic procedure Background Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | intolerance to Angiotensin-Converting Enzyme Inhibitors | intolerance to Angiotensin II receptor antagonist | intolerance to Adrenergic beta-Antagonists ,
Item
background heart failure therapy that includes angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blockers (arbs), and beta blockers (bbs) for at least 3 months (or documentation of intolerance to acei/arbs and bbs)
boolean
C0087111 (UMLS CUI [1,1])
C1706907 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0003015 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0521942 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0001645 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
intolerance to Nitrates | intolerance to Hydralazine
Item
no history of intolerance to either nitrates or hydralazine
boolean
C1744706 (UMLS CUI [1,1])
C0028125 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0020223 (UMLS CUI [2,2])
Combination Drug Therapy Hydralazine Nitrates
Item
no treatment with the combination of hydralazine and nitrates for the previous 3 months
boolean
C0013218 (UMLS CUI [1,1])
C0020223 (UMLS CUI [1,2])
C0028125 (UMLS CUI [1,3])
Revascularization | Myocardial Infarction
Item
no revascularization or myocardial infarction within last 90 days
boolean
C0581603 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Cardiac Resynchronization Therapy | Left ventricular ejection fraction
Item
can not be enrolled for at least 90 days after receiving cardiac resynchronization therapy (crt) and must have an lvef (less than or equal to) < 0.35 at least 3 months after crt.
boolean
C1167956 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Heart valve disease | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | myocarditis; active | Uncontrolled hypertension
Item
presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension.
boolean
C0018824 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0238294 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
Pregnancy | Pregnancy, Planned | Pregnancy Preventing Unwilling
Item
women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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