ID

39521

Description

Long-term Prednisone Use for End-stage Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02282683

Lien

https://clinicaltrials.gov/show/NCT02282683

Mots-clés

Versions (1)
  1. 22/01/2020 22/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02282683

Anglais

Eligibility Heart Failure NCT02282683

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
repeated (>2) hospitalizations or ed visits for hf in the past year
Description

Hospitalization Due to Heart Failure Quantity | Emergency department patient visit Quantity Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0018801
inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
Description

Exercise Unable | Including Exertion Limited | Including Intolerance Exertion | Including Resting Symptoms | Including Dependence Inotropic agent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0332257
UMLS CUI [2,2]
C0031807
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0231199
UMLS CUI [3,3]
C0031807
UMLS CUI [4,1]
C0332257
UMLS CUI [4,2]
C0035253
UMLS CUI [4,3]
C1457887
UMLS CUI [5,1]
C0332257
UMLS CUI [5,2]
C0439857
UMLS CUI [5,3]
C0304509
left ventricular ejection fraction ≤35%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
serum uric acid level ≥500μmol/l
Description

Serum uric acid measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0455272
received prednisone treatment during hospitalization period and and more 5 of the followings
Description

Prednisone

Type de données

boolean

Alias
UMLS CUI [1]
C0032952
1. progressive deterioration in renal function (e.g., rise in bun and creatinine)
Description

Renal function Deterioration Progressive | Blood urea increased | Serum creatinine raised

Type de données

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0868945
UMLS CUI [1,3]
C0205329
UMLS CUI [2]
C0151539
UMLS CUI [3]
C0700225
2. weight loss without other cause (e.g., cardiac cachexia)
Description

Weight loss | Independent of Cardiac cachexia

Type de données

boolean

Alias
UMLS CUI [1]
C1262477
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0562491
3. intolerance to ace inhibitors due to hypotension and/or worsening renal function
Description

Intolerance to Angiotensin-Converting Enzyme Inhibitors | Etiology Hypotension | Etiology Renal function Worsening

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0020649
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0232804
UMLS CUI [3,3]
C0332271
4. intolerance to beta blockers due to worsening hf or hypotension
Description

Intolerance to Adrenergic beta-1 Receptor Antagonists | Etiology Heart failure Worsening | Etiology Hypotension

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0304516
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0018801
UMLS CUI [2,3]
C0332271
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0020649
5. frequent systolic blood pressure <90 mm hg
Description

Systolic Pressure Frequent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0332183
6. recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental thizide therapy
Description

Patient need for Diuretics Dose Escalation | Furosemide Equivalent Dose | Thiazide Diuretics Supplemental

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0012798
UMLS CUI [1,3]
C3816728
UMLS CUI [2,1]
C0016860
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C0012802
UMLS CUI [3,2]
C2348609
7. progressive decline in serum sodium, usually to <133 meq/l
Description

Serum sodium decreased Progressive

Type de données

boolean

Alias
UMLS CUI [1,1]
C4048754
UMLS CUI [1,2]
C0205329
8. gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites, or severe lower-extremity edema
Description

Gastrointestinal symptoms | Abdominal discomfort | Nausea | Decrease in appetite | Ascites Disabling | Edema of lower extremity Severe

Type de données

boolean

Alias
UMLS CUI [1]
C0426576
UMLS CUI [2]
C0232487
UMLS CUI [3]
C0027497
UMLS CUI [4]
C0232462
UMLS CUI [5,1]
C0003962
UMLS CUI [5,2]
C4061999
UMLS CUI [6,1]
C0239340
UMLS CUI [6,2]
C0205082
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition (other than heart failure) that could limit the use of prednisone
Description

Condition Limiting Use of Prednisone | Exception Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0032952
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
any concurrent disease that likely limits life expectancy;
Description

Comorbidity Limiting Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
Description

Myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy

Type de données

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
Description

Myocardial Infarction | Cerebrovascular accident | Angina, Unstable | Cardiac Surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018821
indication for hemodialysis
Description

Indication Hemodialysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0019004
uncontrolled systolic blood pressure > 160 mmhg
Description

Systolic Pressure Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205318
complex congenital heart disease
Description

Complex congenital heart disease

Type de données

boolean

Alias
UMLS CUI [1]
C0744669
poorly controlled diabetes
Description

Poorly controlled diabetes mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0554876
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Similar models

Eligibility Heart Failure NCT02282683

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Due to Heart Failure Quantity | Emergency department patient visit Quantity Heart failure
Item
repeated (>2) hospitalizations or ed visits for hf in the past year
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Exercise Unable | Including Exertion Limited | Including Intolerance Exertion | Including Resting Symptoms | Including Dependence Inotropic agent
Item
inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
boolean
C0015259 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0332257 (UMLS CUI [2,1])
C0031807 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0332257 (UMLS CUI [3,1])
C0231199 (UMLS CUI [3,2])
C0031807 (UMLS CUI [3,3])
C0332257 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C1457887 (UMLS CUI [4,3])
C0332257 (UMLS CUI [5,1])
C0439857 (UMLS CUI [5,2])
C0304509 (UMLS CUI [5,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction ≤35%
boolean
C0428772 (UMLS CUI [1])
Serum uric acid measurement
Item
serum uric acid level ≥500μmol/l
boolean
C0455272 (UMLS CUI [1])
Prednisone
Item
received prednisone treatment during hospitalization period and and more 5 of the followings
boolean
C0032952 (UMLS CUI [1])
Renal function Deterioration Progressive | Blood urea increased | Serum creatinine raised
Item
1. progressive deterioration in renal function (e.g., rise in bun and creatinine)
boolean
C0232804 (UMLS CUI [1,1])
C0868945 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0151539 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
Weight loss | Independent of Cardiac cachexia
Item
2. weight loss without other cause (e.g., cardiac cachexia)
boolean
C1262477 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0562491 (UMLS CUI [2,2])
Intolerance to Angiotensin-Converting Enzyme Inhibitors | Etiology Hypotension | Etiology Renal function Worsening
Item
3. intolerance to ace inhibitors due to hypotension and/or worsening renal function
boolean
C1744706 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0020649 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0232804 (UMLS CUI [3,2])
C0332271 (UMLS CUI [3,3])
Intolerance to Adrenergic beta-1 Receptor Antagonists | Etiology Heart failure Worsening | Etiology Hypotension
Item
4. intolerance to beta blockers due to worsening hf or hypotension
boolean
C1744706 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0332271 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0020649 (UMLS CUI [3,2])
Systolic Pressure Frequent
Item
5. frequent systolic blood pressure <90 mm hg
boolean
C0871470 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
Patient need for Diuretics Dose Escalation | Furosemide Equivalent Dose | Thiazide Diuretics Supplemental
Item
6. recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental thizide therapy
boolean
C0686904 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
C3816728 (UMLS CUI [1,3])
C0016860 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0012802 (UMLS CUI [3,1])
C2348609 (UMLS CUI [3,2])
Serum sodium decreased Progressive
Item
7. progressive decline in serum sodium, usually to <133 meq/l
boolean
C4048754 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Gastrointestinal symptoms | Abdominal discomfort | Nausea | Decrease in appetite | Ascites Disabling | Edema of lower extremity Severe
Item
8. gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites, or severe lower-extremity edema
boolean
C0426576 (UMLS CUI [1])
C0232487 (UMLS CUI [2])
C0027497 (UMLS CUI [3])
C0232462 (UMLS CUI [4])
C0003962 (UMLS CUI [5,1])
C4061999 (UMLS CUI [5,2])
C0239340 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Condition Limiting Use of Prednisone | Exception Heart failure
Item
any condition (other than heart failure) that could limit the use of prednisone
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0032952 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Comorbidity Limiting Life Expectancy
Item
any concurrent disease that likely limits life expectancy;
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy
Item
active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
boolean
C0027059 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
Myocardial Infarction | Cerebrovascular accident | Angina, Unstable | Cardiac Surgery
Item
myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
Indication Hemodialysis
Item
indication for hemodialysis
boolean
C3146298 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
Systolic Pressure Uncontrolled
Item
uncontrolled systolic blood pressure > 160 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Complex congenital heart disease
Item
complex congenital heart disease
boolean
C0744669 (UMLS CUI [1])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
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