ID

39390

Beschrijving

Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels; ODM derived from: https://clinicaltrials.gov/show/NCT00987415

Link

https://clinicaltrials.gov/show/NCT00987415

Trefwoorden

Versies (1)
  1. 06-01-20 06-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00987415

Engels

Eligibility Heart Failure NCT00987415

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha class ii-iv heart failure due to ischemic or non-ischemic cardiomyopathy.
Beschrijving

Heart failure New York Heart Association Classification | Etiology Ischemic cardiomyopathy | Etiology Non-ischemic cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0349782
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0877438
left ventricular ejection fraction ≤ 40% by echocardiography- heart failure symptoms for 3 months despite standard treatment.
Beschrijving

Left ventricular ejection fraction Echocardiography | Symptoms Heart failure Duration | Standard therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0018801
UMLS CUI [2,3]
C0449238
UMLS CUI [3]
C2936643
serum uric acid level ≥ 9.5 mg/dl.
Beschrijving

Serum uric acid measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0455272
at least one of the following additional markers of increased risk: hospitalization, er visit or urgent clinic visit for heart failure requiring iv diuretics within the previous 12 months; left ventricular ejection fraction ≤ 25; b-type natriuretic peptide level > 250 pg/ml
Beschrijving

Markers Quantity High risk | Hospitalization Due to Heart Failure | ER Visit Due to Heart Failure | Clinic Visit Urgent Heart failure | Requirement Diuretics Intravenous | Left ventricular ejection fraction | Brain natriuretic peptide measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008963
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C4319571
UMLS CUI [2]
C3898876
UMLS CUI [3]
C3899311
UMLS CUI [4,1]
C0008952
UMLS CUI [4,2]
C0439609
UMLS CUI [4,3]
C0018801
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0012798
UMLS CUI [5,3]
C1522726
UMLS CUI [6]
C0428772
UMLS CUI [7]
C1095989
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
Beschrijving

Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive | Myocarditis | Valvular stenosis Severe | Complex congenital heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0007196
UMLS CUI [3]
C0031048
UMLS CUI [4]
C0027059
UMLS CUI [5,1]
C1883524
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0744669
acute coronary syndrome, pci or cabg within 3 months.
Beschrijving

Acute Coronary Syndrome | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
Beschrijving

Artificial Ventricle | Artificial Ventricle Expected | Heart Transplantation Expected

Datatype

boolean

Alias
UMLS CUI [1]
C0085842
UMLS CUI [2,1]
C0085842
UMLS CUI [2,2]
C1517001
UMLS CUI [3,1]
C0018823
UMLS CUI [3,2]
C1517001
uncontrolled hypertension (i.e., sbp > 170 mm hg or dbp > 110 mm hg)
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
serum creatinine > 3 mg/dl or estimated gfr < 20 ml/min.
Beschrijving

Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3811844
evidence of active hepatitis with alt and ast greater than 3x normal.
Beschrijving

Hepatitis | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
any condition other than hf which could limit the ability to perform a 6-minute walk test
Beschrijving

Condition Limiting 6-Minute Walk Test | Exception Heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0430515
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
any diseases other than hf which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
Beschrijving

Disease Changing Perceived quality of life | Exception Heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0518214
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
Beschrijving

Allopurinol | Hyperuricemia Symptomatic | Requirement Allopurinol

Datatype

boolean

Alias
UMLS CUI [1]
C0002144
UMLS CUI [2,1]
C0740394
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0002144
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Similar models

Eligibility Heart Failure NCT00987415

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure New York Heart Association Classification | Etiology Ischemic cardiomyopathy | Etiology Non-ischemic cardiomyopathy
Item
nyha class ii-iv heart failure due to ischemic or non-ischemic cardiomyopathy.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0349782 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0877438 (UMLS CUI [3,2])
Left ventricular ejection fraction Echocardiography | Symptoms Heart failure Duration | Standard therapy
Item
left ventricular ejection fraction ≤ 40% by echocardiography- heart failure symptoms for 3 months despite standard treatment.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C2936643 (UMLS CUI [3])
Serum uric acid measurement
Item
serum uric acid level ≥ 9.5 mg/dl.
boolean
C0455272 (UMLS CUI [1])
Markers Quantity High risk | Hospitalization Due to Heart Failure | ER Visit Due to Heart Failure | Clinic Visit Urgent Heart failure | Requirement Diuretics Intravenous | Left ventricular ejection fraction | Brain natriuretic peptide measurement
Item
at least one of the following additional markers of increased risk: hospitalization, er visit or urgent clinic visit for heart failure requiring iv diuretics within the previous 12 months; left ventricular ejection fraction ≤ 25; b-type natriuretic peptide level > 250 pg/ml
boolean
C0008963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4319571 (UMLS CUI [1,3])
C3898876 (UMLS CUI [2])
C3899311 (UMLS CUI [3])
C0008952 (UMLS CUI [4,1])
C0439609 (UMLS CUI [4,2])
C0018801 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C0012798 (UMLS CUI [5,2])
C1522726 (UMLS CUI [5,3])
C0428772 (UMLS CUI [6])
C1095989 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive | Myocarditis | Valvular stenosis Severe | Complex congenital heart disease
Item
hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
boolean
C0007194 (UMLS CUI [1])
C0007196 (UMLS CUI [2])
C0031048 (UMLS CUI [3])
C0027059 (UMLS CUI [4])
C1883524 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0744669 (UMLS CUI [6])
Acute Coronary Syndrome | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
acute coronary syndrome, pci or cabg within 3 months.
boolean
C0948089 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Artificial Ventricle | Artificial Ventricle Expected | Heart Transplantation Expected
Item
current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
boolean
C0085842 (UMLS CUI [1])
C0085842 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0018823 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (i.e., sbp > 170 mm hg or dbp > 110 mm hg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
serum creatinine > 3 mg/dl or estimated gfr < 20 ml/min.
boolean
C0201976 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Hepatitis | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
evidence of active hepatitis with alt and ast greater than 3x normal.
boolean
C0019158 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Condition Limiting 6-Minute Walk Test | Exception Heart failure
Item
any condition other than hf which could limit the ability to perform a 6-minute walk test
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0430515 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Disease Changing Perceived quality of life | Exception Heart failure
Item
any diseases other than hf which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
boolean
C0012634 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0518214 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Allopurinol | Hyperuricemia Symptomatic | Requirement Allopurinol
Item
receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
boolean
C0002144 (UMLS CUI [1])
C0740394 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0002144 (UMLS CUI [3,2])
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