ID

24159

Description

Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial); ODM derived from: https://clinicaltrials.gov/show/NCT00480077

Link

https://clinicaltrials.gov/show/NCT00480077

Keywords

Versions (1)
  1. 7/26/17 7/26/17 -
Uploaded on

July 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00480077

English

Eligibility Heart Failure NCT00480077

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects of both genders with mild to severe hf as defined as nhya class ii to iv who also have an indication for device implant according to esc/aha guidelines as well as having a hf hospitalization or emergency department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study.
Description

Gender | Heart failure New York Heart Association Classification | Indication Implant device | Hospitalization Due to Heart Failure | Emergency department visit Due to Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0021102
UMLS CUI [4]
C3898876
UMLS CUI [5,1]
C0586082
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
Description

Heart Transplantation Status post | On transplant waiting list | Heart Transplantation Receive Probability

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0231290
UMLS CUI [2]
C3484394
UMLS CUI [3,1]
C0018823
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0033204
subject received a coronary artery bypass graft or valve surgery in last 90 days
Description

Coronary Artery Bypass Surgery | Operation on heart valve

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0190065
subject with a myocardial infarction (mi) in the last 40 days.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
subject's life expectancy is less than one year in the opinion of the physician
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subject has severe chronic obstructive pulmonary disease (copd), as determined by physician and documented in medical records
Description

Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0730607
subject is listed for valve replacement/valve repair
Description

Patient on waiting list Valve replacement | Patient on waiting list Repair of heart valve

Data type

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C1410969
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0190112
subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records
Description

Pulmonary Hypertension Primary Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205082
subject with serum creatinine ≥ 2.5 mg/dl measured within 14 days prior to enrolment
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
subject on chronic renal dialysis
Description

Renal dialysis chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0205191
subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for hf
Description

Infusion Inotropic agent | Infusion Quantity Stable Weekly

Data type

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0304509
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0332174
subject has complex and uncorrected congenital heart disease
Description

Congenital heart disease complex uncorrected

Data type

boolean

Alias
UMLS CUI [1,1]
C0152021
UMLS CUI [1,2]
C0439855
UMLS CUI [1,3]
C4072785
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Similar models

Eligibility Heart Failure NCT00480077

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Heart failure New York Heart Association Classification | Indication Implant device | Hospitalization Due to Heart Failure | Emergency department visit Due to Heart failure
Item
subjects of both genders with mild to severe hf as defined as nhya class ii to iv who also have an indication for device implant according to esc/aha guidelines as well as having a hf hospitalization or emergency department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study.
boolean
C0079399 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C3898876 (UMLS CUI [4])
C0586082 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0018801 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation Status post | On transplant waiting list | Heart Transplantation Receive Probability
Item
subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
boolean
C0018823 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C3484394 (UMLS CUI [2])
C0018823 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0033204 (UMLS CUI [3,3])
Coronary Artery Bypass Surgery | Operation on heart valve
Item
subject received a coronary artery bypass graft or valve surgery in last 90 days
boolean
C0010055 (UMLS CUI [1])
C0190065 (UMLS CUI [2])
Myocardial Infarction
Item
subject with a myocardial infarction (mi) in the last 40 days.
boolean
C0027051 (UMLS CUI [1])
Life Expectancy
Item
subject's life expectancy is less than one year in the opinion of the physician
boolean
C0023671 (UMLS CUI [1])
Severe chronic obstructive pulmonary disease
Item
subject has severe chronic obstructive pulmonary disease (copd), as determined by physician and documented in medical records
boolean
C0730607 (UMLS CUI [1])
Patient on waiting list Valve replacement | Patient on waiting list Repair of heart valve
Item
subject is listed for valve replacement/valve repair
boolean
C0422768 (UMLS CUI [1,1])
C1410969 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0190112 (UMLS CUI [2,2])
Pulmonary Hypertension Primary Severe
Item
subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records
boolean
C0020542 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
subject with serum creatinine ≥ 2.5 mg/dl measured within 14 days prior to enrolment
boolean
C0201976 (UMLS CUI [1])
Renal dialysis chronic
Item
subject on chronic renal dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Infusion Inotropic agent | Infusion Quantity Stable Weekly
Item
subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for hf
boolean
C0574032 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0332174 (UMLS CUI [2,4])
Congenital heart disease complex uncorrected
Item
subject has complex and uncorrected congenital heart disease
boolean
C0152021 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
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