ID

17445

Description

Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF); ODM derived from: https://clinicaltrials.gov/show/NCT00643279

Link

https://clinicaltrials.gov/show/NCT00643279

Keywords

Versions (1)
  1. 9/14/16 9/14/16 -
Uploaded on

September 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00643279

English

Eligibility Heart Failure NCT00643279

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with heart failure classified as new york heart association (nyha) class iii and iv
Description

Heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blockers (arb), and beta-blocker for at least 3 months prior to the baseline evaluation
Description

Standard of Care Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0001645
subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
Description

Hospitalization Quantity Related Heart failure | Emergency department visit Quantity Related Heart failure | Intravenous therapy Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0018801
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0018801
UMLS CUI [3,1]
C0455142
UMLS CUI [3,2]
C0686904
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
Description

Transplantation Probably | Hospitalization Until Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0750492
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1720302
UMLS CUI [2,3]
C0040732
subjects with severe copd or restrictive airway disease (recommended fev1 less than or equal to 1 liter or 50% predicted)
Description

Severe chronic obstructive pulmonary disease | airway disease restrictive | FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0740850
UMLS CUI [3]
C0748133
subjects who are on continuous positive inotropic therapy
Description

Therapeutic procedure Inotropic agent Positive Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0549178
subjects with known atrial or ventricular septal defects
Description

Atrial Septal Defects | Ventricular Septal Defects

Data type

boolean

Alias
UMLS CUI [1]
C0018817
UMLS CUI [2]
C0018818
subjects with mechanical right heart valves
Description

HEART-VALVE, MECHANICAL Right

Data type

boolean

Alias
UMLS CUI [1,1]
C0493527
UMLS CUI [1,2]
C0205090
subjects with stenotic tricuspid or pulmonary valves
Description

Tricuspid Valve Stenosis | Pulmonary Valve Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0040963
UMLS CUI [2]
C0034089
subjects with a presently implanted non-compatible pacemaker or icd
Description

pacemaker implant Compatible | Implantable defibrillator Compatible

Data type

boolean

Alias
UMLS CUI [1,1]
C0848753
UMLS CUI [1,2]
C1524057
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C1524057
subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
Description

Cardiac Resynchronization Therapy Suboptimal

Data type

boolean

Alias
UMLS CUI [1,1]
C1167956
UMLS CUI [1,2]
C2984009
subjects with a major cardiovascular event within 3 months prior to baseline evaluation
Description

Cardiovascular event Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
subjects with a severe non-cardiac condition limiting 6 month survival
Description

Condition Severe Limiting Survival time

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C2919552
subjects with a primary diagnosis of pulmonary artery hypertension
Description

Pulmonary Hypertension Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0332137
subjects with serum creatinine greater than or equal to 3.5 mg/dl or on chronic renal dialysis
Description

Creatinine measurement, serum | Dialysis procedure chronic

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0205191
subjects enrolled in concurrent studies that may confound the results of this study
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
women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Description

Pregnancy | Childbearing Potential Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205412
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Similar models

Eligibility Heart Failure NCT00643279

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
subjects with heart failure classified as new york heart association (nyha) class iii and iv
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Standard of Care Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists
Item
subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blockers (arb), and beta-blocker for at least 3 months prior to the baseline evaluation
boolean
C2936643 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
Hospitalization Quantity Related Heart failure | Emergency department visit Quantity Related Heart failure | Intravenous therapy Patient need for
Item
subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0018801 (UMLS CUI [2,4])
C0455142 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Transplantation Probably | Hospitalization Until Transplantation
Item
subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
boolean
C0040732 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1720302 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Severe chronic obstructive pulmonary disease | airway disease restrictive | FEV1
Item
subjects with severe copd or restrictive airway disease (recommended fev1 less than or equal to 1 liter or 50% predicted)
boolean
C0730607 (UMLS CUI [1])
C0740850 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
Therapeutic procedure Inotropic agent Positive Continuous
Item
subjects who are on continuous positive inotropic therapy
boolean
C0087111 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Atrial Septal Defects | Ventricular Septal Defects
Item
subjects with known atrial or ventricular septal defects
boolean
C0018817 (UMLS CUI [1])
C0018818 (UMLS CUI [2])
HEART-VALVE, MECHANICAL Right
Item
subjects with mechanical right heart valves
boolean
C0493527 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Tricuspid Valve Stenosis | Pulmonary Valve Stenosis
Item
subjects with stenotic tricuspid or pulmonary valves
boolean
C0040963 (UMLS CUI [1])
C0034089 (UMLS CUI [2])
pacemaker implant Compatible | Implantable defibrillator Compatible
Item
subjects with a presently implanted non-compatible pacemaker or icd
boolean
C0848753 (UMLS CUI [1,1])
C1524057 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C1524057 (UMLS CUI [2,2])
Cardiac Resynchronization Therapy Suboptimal
Item
subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
boolean
C1167956 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
Cardiovascular event Major
Item
subjects with a major cardiovascular event within 3 months prior to baseline evaluation
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Condition Severe Limiting Survival time
Item
subjects with a severe non-cardiac condition limiting 6 month survival
boolean
C0348080 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C2919552 (UMLS CUI [1,4])
Pulmonary Hypertension Principal diagnosis
Item
subjects with a primary diagnosis of pulmonary artery hypertension
boolean
C0020542 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Creatinine measurement, serum | Dialysis procedure chronic
Item
subjects with serum creatinine greater than or equal to 3.5 mg/dl or on chronic renal dialysis
boolean
C0201976 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with research results
Item
subjects enrolled in concurrent studies that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Pregnancy | Childbearing Potential Contraceptive methods Inadequate
Item
women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
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