ID

40345

Beschrijving

Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension?; ODM derived from: https://clinicaltrials.gov/show/NCT02237339

Link

https://clinicaltrials.gov/show/NCT02237339

Trefwoorden

Versies (1)
  1. 10-04-20 10-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT02237339

Engels

Eligibility Hypertension NCT02237339

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
are aged over 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
previously diagnosed with essential hypertension
Beschrijving

Essential Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
been on stable antihypertensive therapy for at least 3 months prior to study screening
Beschrijving

Antihypertensive therapy Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0205360
have screening ambulatory bloods pressure monitoring (abpm) or home based bp monitoring if abpm not tolerated with daytime average systolic <135mmhg
Beschrijving

Blood Pressure Monitoring, Ambulatory | Blood Pressure Monitoring, Home | Systolic Pressure Daytime Average

Datatype

boolean

Alias
UMLS CUI [1]
C0242876
UMLS CUI [2]
C1449681
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0332169
UMLS CUI [3,3]
C1510992
have screening echocardiography based diagnosis of left ventricular hypertrophy (lvh) based on american society of echocardiography (ase) criteria (males >115g/m2, females >95g/m2)
Beschrijving

Left Ventricular Hypertrophy Echocardiography | Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149721
UMLS CUI [1,2]
C0013516
UMLS CUI [2]
C0079399
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented intolerance to allopurinol
Beschrijving

Intolerance to Allopurinol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0002144
left ventricular ejection fraction <45% on echocardiography screening
Beschrijving

Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
severe aortic stenosis on echocardiography screening
Beschrijving

Severe aortic stenosis Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C3806272
UMLS CUI [1,2]
C0013516
active gout (i.e. flare within two years) or currently on allopurinol
Beschrijving

Gout | Gout flare | Allopurinol

Datatype

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C1619733
UMLS CUI [3]
C0002144
severe hepatic disease
Beschrijving

Liver disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
renal disease; chronic kidney disease (ckd) class 3b or worse
Beschrijving

Kidney Disease | Chronic Kidney Disease Stage

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C2074731
on azathioprine, 6 mercaptopurine, or theophylline
Beschrijving

Azathioprine | mercaptopurine | Theophylline

Datatype

boolean

Alias
UMLS CUI [1]
C0004482
UMLS CUI [2]
C0000618
UMLS CUI [3]
C0039771
malignancy (receiving active treatment) or other life threatening diseases
Beschrijving

Malignant Neoplasms | Cancer treatment | Life threatening illness

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3]
C3846017
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any contraindication to magnetic resonance imaging (mri) (claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention).
Beschrijving

Medical contraindication Magnetic Resonance Imaging | Claustrophobia | Metallic implant | Eye Injuries, Penetrating | Exposure to Metal foreign body in eye region

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0015409
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0562528
patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days will be excluded.
Beschrijving

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
patients who are unable to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
any other considered by a study physician to be inappropriate for inclusion.
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Hypertension NCT02237339

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
are aged over 18 years
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
previously diagnosed with essential hypertension
boolean
C0085580 (UMLS CUI [1])
Antihypertensive therapy Stable
Item
been on stable antihypertensive therapy for at least 3 months prior to study screening
boolean
C0585941 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Blood Pressure Monitoring, Ambulatory | Blood Pressure Monitoring, Home | Systolic Pressure Daytime Average
Item
have screening ambulatory bloods pressure monitoring (abpm) or home based bp monitoring if abpm not tolerated with daytime average systolic <135mmhg
boolean
C0242876 (UMLS CUI [1])
C1449681 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0332169 (UMLS CUI [3,2])
C1510992 (UMLS CUI [3,3])
Left Ventricular Hypertrophy Echocardiography | Gender
Item
have screening echocardiography based diagnosis of left ventricular hypertrophy (lvh) based on american society of echocardiography (ase) criteria (males >115g/m2, females >95g/m2)
boolean
C0149721 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Intolerance to Allopurinol
Item
documented intolerance to allopurinol
boolean
C1744706 (UMLS CUI [1,1])
C0002144 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction <45% on echocardiography screening
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Severe aortic stenosis Echocardiography
Item
severe aortic stenosis on echocardiography screening
boolean
C3806272 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Gout | Gout flare | Allopurinol
Item
active gout (i.e. flare within two years) or currently on allopurinol
boolean
C0018099 (UMLS CUI [1])
C1619733 (UMLS CUI [2])
C0002144 (UMLS CUI [3])
Liver disease Severe
Item
severe hepatic disease
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Disease | Chronic Kidney Disease Stage
Item
renal disease; chronic kidney disease (ckd) class 3b or worse
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2,1])
C2074731 (UMLS CUI [2,2])
Azathioprine | mercaptopurine | Theophylline
Item
on azathioprine, 6 mercaptopurine, or theophylline
boolean
C0004482 (UMLS CUI [1])
C0000618 (UMLS CUI [2])
C0039771 (UMLS CUI [3])
Malignant Neoplasms | Cancer treatment | Life threatening illness
Item
malignancy (receiving active treatment) or other life threatening diseases
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C3846017 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Magnetic Resonance Imaging | Claustrophobia | Metallic implant | Eye Injuries, Penetrating | Exposure to Metal foreign body in eye region
Item
any contraindication to magnetic resonance imaging (mri) (claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0015409 (UMLS CUI [4])
C0332157 (UMLS CUI [5,1])
C0562528 (UMLS CUI [5,2])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days will be excluded.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Informed Consent Unable
Item
patients who are unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
any other considered by a study physician to be inappropriate for inclusion.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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