ID

20833

Description

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf); ODM derived from: https://clinicaltrials.gov/show/NCT00354159

Link

https://clinicaltrials.gov/show/NCT00354159

Keywords

  1. 3/21/17 3/21/17 -
Uploaded on

March 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00354159

Eligibility Heart Failure NCT00354159

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with heart failure that only sometimes interferes with daily activities (new york heart association [nyha] class ii (1)) or subjects with heart failure which severely limits daily activities (nyha class iii (2)) at baseline
Description

Heart failure NYHA Interferes with daily activities Sometimes | Heart failure NYHA Limiting Severe daily activities

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0871707
UMLS CUI [1,5]
C1998882
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0205082
UMLS CUI [2,5]
C0871707
subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb) and beta blocker) for at least three months prior to the baseline evaluation.
Description

Therapeutic procedure Appropriate Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0304516
subject has been on stable medications maximized to the subject's tolerance of ace or arb and beta blockers as determined by the study investigator for at least 30 days prior to baseline evaluation. (stable is defined as no more than a 100% increase or a 50% decrease in dose.) if a subject is intolerant of ace, arb or beta blockers documented evidence must be available.
Description

Pharmaceutical Preparations Stable | Tolerance Peptidyl-Dipeptidase A | Tolerance Angiotensin II receptor antagonist | Tolerance Adrenergic beta-1 Receptor Antagonists | Intolerance to Peptidyl-Dipeptidase A | Intolerance to Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0231197
UMLS CUI [2,2]
C0022709
UMLS CUI [3,1]
C0231197
UMLS CUI [3,2]
C0521942
UMLS CUI [4,1]
C0231197
UMLS CUI [4,2]
C0304516
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0022709
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0521942
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0304516
subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation
Description

Hospitalization Quantity Due to Heart failure | Emergency department patient visit Quantity | Urgent Care Patient Visit Quantity | Heart failure Intravenous therapy Patient need for | Diuretics intravenous administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0018801
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C2362545
UMLS CUI [3,2]
C1512346
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0455142
UMLS CUI [4,3]
C0686904
UMLS CUI [5,1]
C0012798
UMLS CUI [5,2]
C0013125
to be considered for chronicle icd: subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (icd).
Description

Heart beat Abnormal Rapid | Implantable defibrillator Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0425583
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0456962
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0686904
1. class ii subjects with cardiac disease resulting in slight limitation of physical activity. they are comfortable at rest. ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.
Description

Heart Disease New York Heart Association Classification | Physical activity Limitation Slight | Physical activity Resulting in Fatigue | Physical activity Resulting in Palpitations | Physical activity Resulting in Dyspnea | Physical activity Resulting in Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0449295
UMLS CUI [2,3]
C2937276
UMLS CUI [3,1]
C0026606
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0015672
UMLS CUI [4,1]
C0026606
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0030252
UMLS CUI [5,1]
C0026606
UMLS CUI [5,2]
C0332294
UMLS CUI [5,3]
C0013404
UMLS CUI [6,1]
C0026606
UMLS CUI [6,2]
C0332294
UMLS CUI [6,3]
C0002962
2. class iii subjects with cardiac disease resulting in marked limitation of physical activity. they are comfortable at rest. less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.
Description

Heart Disease New York Heart Association Classification | Physical activity Limitation Marked | Physical activity Slight Resulting in Fatigue | Physical activity Slight Resulting in Palpitations | Physical activity Slight Resulting in Dyspnea | Physical activity Slight Resulting in Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0449295
UMLS CUI [2,3]
C1706089
UMLS CUI [3,1]
C0026606
UMLS CUI [3,2]
C2937276
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0015672
UMLS CUI [4,1]
C0026606
UMLS CUI [4,2]
C2937276
UMLS CUI [4,3]
C0332294
UMLS CUI [4,4]
C0030252
UMLS CUI [5,1]
C0026606
UMLS CUI [5,2]
C2937276
UMLS CUI [5,3]
C0332294
UMLS CUI [5,4]
C0013404
UMLS CUI [6,1]
C0026606
UMLS CUI [6,2]
C2937276
UMLS CUI [6,3]
C0332294
UMLS CUI [6,4]
C0002962
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with severe heart failure who should always be resting (nyha class iv(3)) or stage d(4) refractory heart failure.
Description

Heart failure Severe New York Heart Association Classification | Refractory heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C1281998
UMLS CUI [2,2]
C1275491
subjects with severe renal dysfunction.
Description

Renal dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
subjects with severe non-cardiac condition limiting 12-month survival.
Description

Condition Severe Limiting Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
subjects in concurrent studies that may confound the results.
Description

Study Subject Participation Status Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
(3)class iv subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. symptoms of heart failure or the anginal syndrome may be present even at rest. if any physical activity is undertaken, discomfort is increased.
Description

Heart Disease New York Heart Association Classification | Heart Disease Resulting in Physical activity Discomfort | Heart failure Symptoms At rest | Angina Pectoris Symptoms At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0026606
UMLS CUI [2,4]
C2364135
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0443144
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C0443144
(4)stage d refractory heart failure: patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)
Description

Refractory heart failure New York Heart Association Classification | Therapeutic procedure Maximal | Symptoms Marked At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C1281998
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0806909
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1706089
UMLS CUI [3,3]
C0443144

Similar models

Eligibility Heart Failure NCT00354159

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure NYHA Interferes with daily activities Sometimes | Heart failure NYHA Limiting Severe daily activities
Item
subjects with heart failure that only sometimes interferes with daily activities (new york heart association [nyha] class ii (1)) or subjects with heart failure which severely limits daily activities (nyha class iii (2)) at baseline
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0871707 (UMLS CUI [1,4])
C1998882 (UMLS CUI [1,5])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
C0871707 (UMLS CUI [2,5])
Therapeutic procedure Appropriate Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists
Item
subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb) and beta blocker) for at least three months prior to the baseline evaluation.
boolean
C0087111 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
Pharmaceutical Preparations Stable | Tolerance Peptidyl-Dipeptidase A | Tolerance Angiotensin II receptor antagonist | Tolerance Adrenergic beta-1 Receptor Antagonists | Intolerance to Peptidyl-Dipeptidase A | Intolerance to Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists
Item
subject has been on stable medications maximized to the subject's tolerance of ace or arb and beta blockers as determined by the study investigator for at least 30 days prior to baseline evaluation. (stable is defined as no more than a 100% increase or a 50% decrease in dose.) if a subject is intolerant of ace, arb or beta blockers documented evidence must be available.
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0231197 (UMLS CUI [2,1])
C0022709 (UMLS CUI [2,2])
C0231197 (UMLS CUI [3,1])
C0521942 (UMLS CUI [3,2])
C0231197 (UMLS CUI [4,1])
C0304516 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0022709 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0521942 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0304516 (UMLS CUI [7,2])
Hospitalization Quantity Due to Heart failure | Emergency department patient visit Quantity | Urgent Care Patient Visit Quantity | Heart failure Intravenous therapy Patient need for | Diuretics intravenous administration
Item
subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2362545 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4,1])
C0455142 (UMLS CUI [4,2])
C0686904 (UMLS CUI [4,3])
C0012798 (UMLS CUI [5,1])
C0013125 (UMLS CUI [5,2])
Heart beat Abnormal Rapid | Implantable defibrillator Patient need for
Item
to be considered for chronicle icd: subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (icd).
boolean
C0425583 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0456962 (UMLS CUI [1,3])
C0162589 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Heart Disease New York Heart Association Classification | Physical activity Limitation Slight | Physical activity Resulting in Fatigue | Physical activity Resulting in Palpitations | Physical activity Resulting in Dyspnea | Physical activity Resulting in Angina Pectoris
Item
1. class ii subjects with cardiac disease resulting in slight limitation of physical activity. they are comfortable at rest. ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
C2937276 (UMLS CUI [2,3])
C0026606 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0015672 (UMLS CUI [3,3])
C0026606 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0030252 (UMLS CUI [4,3])
C0026606 (UMLS CUI [5,1])
C0332294 (UMLS CUI [5,2])
C0013404 (UMLS CUI [5,3])
C0026606 (UMLS CUI [6,1])
C0332294 (UMLS CUI [6,2])
C0002962 (UMLS CUI [6,3])
Heart Disease New York Heart Association Classification | Physical activity Limitation Marked | Physical activity Slight Resulting in Fatigue | Physical activity Slight Resulting in Palpitations | Physical activity Slight Resulting in Dyspnea | Physical activity Slight Resulting in Angina Pectoris
Item
2. class iii subjects with cardiac disease resulting in marked limitation of physical activity. they are comfortable at rest. less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
C1706089 (UMLS CUI [2,3])
C0026606 (UMLS CUI [3,1])
C2937276 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0015672 (UMLS CUI [3,4])
C0026606 (UMLS CUI [4,1])
C2937276 (UMLS CUI [4,2])
C0332294 (UMLS CUI [4,3])
C0030252 (UMLS CUI [4,4])
C0026606 (UMLS CUI [5,1])
C2937276 (UMLS CUI [5,2])
C0332294 (UMLS CUI [5,3])
C0013404 (UMLS CUI [5,4])
C0026606 (UMLS CUI [6,1])
C2937276 (UMLS CUI [6,2])
C0332294 (UMLS CUI [6,3])
C0002962 (UMLS CUI [6,4])
Item Group
C0680251 (UMLS CUI)
Heart failure Severe New York Heart Association Classification | Refractory heart failure New York Heart Association Classification
Item
subjects with severe heart failure who should always be resting (nyha class iv(3)) or stage d(4) refractory heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C1281998 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Renal dysfunction Severe
Item
subjects with severe renal dysfunction.
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Condition Severe Limiting Life Expectancy
Item
subjects with severe non-cardiac condition limiting 12-month survival.
boolean
C0348080 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
Study Subject Participation Status Interferes with Research results
Item
subjects in concurrent studies that may confound the results.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Heart Disease New York Heart Association Classification | Heart Disease Resulting in Physical activity Discomfort | Heart failure Symptoms At rest | Angina Pectoris Symptoms At rest
Item
(3)class iv subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. symptoms of heart failure or the anginal syndrome may be present even at rest. if any physical activity is undertaken, discomfort is increased.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
C2364135 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0443144 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0443144 (UMLS CUI [4,3])
Refractory heart failure New York Heart Association Classification | Therapeutic procedure Maximal | Symptoms Marked At rest
Item
(4)stage d refractory heart failure: patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)
boolean
C1281998 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C1706089 (UMLS CUI [3,2])
C0443144 (UMLS CUI [3,3])

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