ID

33795

Description

Lung Impedance Monitoring In Treatment of Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01320007

Link

https://clinicaltrials.gov/show/NCT01320007

Keywords

Versions (1)
  1. 12/27/18 12/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01320007

English

Eligibility Heart Failure NCT01320007

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously fitted with an icd or a crt-d device for primary or secondary prevention (for at least 34 days) with a medtronic optivol capable device
Description

ICD Primary Prevention | CRT-D Primary Prevention | ICD Secondary Prevention | CRT-D Secondary Prevention | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0033144
UMLS CUI [2,1]
C4270801
UMLS CUI [2,2]
C0033144
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C0679699
UMLS CUI [4,1]
C4270801
UMLS CUI [4,2]
C0679699
UMLS CUI [5]
C3846158
previous hospital admission for decompensated heart failure
Description

Hospital admission Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0581377
left ventricular systolic dysfunction (ef <50%)
Description

Left ventricular systolic dysfunction | Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1277187
UMLS CUI [2]
C0232174
currently compensated heart failure with a functional class of iii or better
Description

Heart failure Compensated New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205432
UMLS CUI [1,3]
C1275491
all patients will be on optimal medical treatment including a beta blocker, an acei (or arb) and spironolactone unless contraindicated or not tolerated
Description

Therapeutic procedure Optimal | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Spironolactone | Exception Medical contraindication | Exception Intolerance to substance

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0037982
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1301624
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1744706
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated patients who have nyha class iv or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their nyha class improves)
Description

Decompensated cardiac failure New York Heart Association Classification | Sign or Symptom Pulmonary congestion

Data type

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0242073
patients with a high optivol fluid index at time of evaluation (these patients may be included later when the optivol fluid index comes down)
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
patients with advanced renal failure ± dialysis (chronic kidney disease class 4 or 5 with an estimated gfr of <30 ml/min)
Description

Kidney Failure Advanced | Dialysis | Dialysis Absent | Chronic kidney disease stage | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0011946
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C2074731
UMLS CUI [5]
C3811844
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Similar models

Eligibility Heart Failure NCT01320007

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ICD Primary Prevention | CRT-D Primary Prevention | ICD Secondary Prevention | CRT-D Secondary Prevention | Other Coding
Item
previously fitted with an icd or a crt-d device for primary or secondary prevention (for at least 34 days) with a medtronic optivol capable device
boolean
C0162589 (UMLS CUI [1,1])
C0033144 (UMLS CUI [1,2])
C4270801 (UMLS CUI [2,1])
C0033144 (UMLS CUI [2,2])
C0162589 (UMLS CUI [3,1])
C0679699 (UMLS CUI [3,2])
C4270801 (UMLS CUI [4,1])
C0679699 (UMLS CUI [4,2])
C3846158 (UMLS CUI [5])
Hospital admission Decompensated cardiac failure
Item
previous hospital admission for decompensated heart failure
boolean
C0184666 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
Left ventricular systolic dysfunction | Cardiac ejection fraction
Item
left ventricular systolic dysfunction (ef <50%)
boolean
C1277187 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
Heart failure Compensated New York Heart Association Classification
Item
currently compensated heart failure with a functional class of iii or better
boolean
C0018801 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Therapeutic procedure Optimal | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Spironolactone | Exception Medical contraindication | Exception Intolerance to substance
Item
all patients will be on optimal medical treatment including a beta blocker, an acei (or arb) and spironolactone unless contraindicated or not tolerated
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0001645 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0037982 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C1301624 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1744706 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Decompensated cardiac failure New York Heart Association Classification | Sign or Symptom Pulmonary congestion
Item
decompensated patients who have nyha class iv or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their nyha class improves)
boolean
C0581377 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0242073 (UMLS CUI [2,2])
Other Coding
Item
patients with a high optivol fluid index at time of evaluation (these patients may be included later when the optivol fluid index comes down)
boolean
C3846158 (UMLS CUI [1])
Kidney Failure Advanced | Dialysis | Dialysis Absent | Chronic kidney disease stage | Estimated Glomerular Filtration Rate
Item
patients with advanced renal failure ± dialysis (chronic kidney disease class 4 or 5 with an estimated gfr of <30 ml/min)
boolean
C0035078 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2074731 (UMLS CUI [4])
C3811844 (UMLS CUI [5])
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