ID

36106

Description

Renal Denervation for Management of Drug-Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01505010

Link

https://clinicaltrials.gov/show/NCT01505010

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01505010

English

Eligibility Hypertension NCT01505010

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women and men are eligible. women of reproductive age should apply effective contraception.
Description

Gender | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
age ranges from 20 years (inclusive) to less than 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients should have essential hypertension.
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
treatment-resistant hypertension in patients taking a stable drug regimen for at least 4 weeks consisting of 3 or more antihypertensive medications from different classes, including a diuretic.
Description

Refractory hypertension | Pharmacotherapy Stable | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretic

Data type

boolean

Alias
UMLS CUI [1]
C0860493
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0456387
UMLS CUI [4,3]
C1705242
UMLS CUI [5]
C0012798
under maximal therapy, office blood pressure should be ≥140/90 mmhg and the 24-h ambulatory blood pressure should be 130 mm hg systolic or 80 mm hg diastolic or higher.
Description

Therapeutic procedure Maximal | Office Blood pressure determination | 24-hour ambulatory blood pressure Systolic | 24-hour ambulatory blood pressure Diastolic

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205289
UMLS CUI [2,1]
C0442603
UMLS CUI [2,2]
C0005824
UMLS CUI [3,1]
C2022220
UMLS CUI [3,2]
C0039155
UMLS CUI [4,1]
C2022220
UMLS CUI [4,2]
C0012000
egfr must be ≥ 60 ml/min/1.73 m2.
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
the patients should accept to have adherence checked before randomisation and during supervised follow-up, but both patients and doctors will remain blinded to the results;
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
informed written consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
suboptimal clinical context, because of recent history or concurrent disease.
Description

Contextual factors Clinical Suboptimal | Medical History | Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0542559
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2984009
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0009488
isolated systolic and diastolic hypertension.
Description

Isolated systolic hypertension | Diastolic hypertension Isolated

Data type

boolean

Alias
UMLS CUI [1]
C0745133
UMLS CUI [2,1]
C0235222
UMLS CUI [2,2]
C0205409
body-mass index ≥ 40kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
the anatomy of the renal arteries is suboptimal for renal denervation.
Description

Anatomy of renal artery Suboptimal Renal artery denervation

Data type

boolean

Alias
UMLS CUI [1,1]
C0700276
UMLS CUI [1,2]
C0035065
UMLS CUI [1,3]
C2984009
UMLS CUI [1,4]
C3544270
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
alcohol or substance abuse or psychiatric illnesses.
Description

Substance Use Disorders | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
participation in other study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
the clinical context is suboptimal for renal denervation.
Description

Contextual factors Clinical Suboptimal Renal artery denervation

Data type

boolean

Alias
UMLS CUI [1,1]
C0542559
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2984009
UMLS CUI [1,4]
C3544270
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Similar models

Eligibility Hypertension NCT01505010

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Childbearing Potential Contraceptive methods
Item
women and men are eligible. women of reproductive age should apply effective contraception.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Age
Item
age ranges from 20 years (inclusive) to less than 70 years.
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
patients should have essential hypertension.
boolean
C0085580 (UMLS CUI [1])
Refractory hypertension | Pharmacotherapy Stable | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretic
Item
treatment-resistant hypertension in patients taking a stable drug regimen for at least 4 weeks consisting of 3 or more antihypertensive medications from different classes, including a diuretic.
boolean
C0860493 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0456387 (UMLS CUI [4,2])
C1705242 (UMLS CUI [4,3])
C0012798 (UMLS CUI [5])
Therapeutic procedure Maximal | Office Blood pressure determination | 24-hour ambulatory blood pressure Systolic | 24-hour ambulatory blood pressure Diastolic
Item
under maximal therapy, office blood pressure should be ≥140/90 mmhg and the 24-h ambulatory blood pressure should be 130 mm hg systolic or 80 mm hg diastolic or higher.
boolean
C0087111 (UMLS CUI [1,1])
C0205289 (UMLS CUI [1,2])
C0442603 (UMLS CUI [2,1])
C0005824 (UMLS CUI [2,2])
C2022220 (UMLS CUI [3,1])
C0039155 (UMLS CUI [3,2])
C2022220 (UMLS CUI [4,1])
C0012000 (UMLS CUI [4,2])
Estimated Glomerular Filtration Rate
Item
egfr must be ≥ 60 ml/min/1.73 m2.
boolean
C3811844 (UMLS CUI [1])
Compliance behavior
Item
the patients should accept to have adherence checked before randomisation and during supervised follow-up, but both patients and doctors will remain blinded to the results;
boolean
C1321605 (UMLS CUI [1])
Informed Consent
Item
informed written consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contextual factors Clinical Suboptimal | Medical History | Comorbidity
Item
suboptimal clinical context, because of recent history or concurrent disease.
boolean
C0542559 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Isolated systolic hypertension | Diastolic hypertension Isolated
Item
isolated systolic and diastolic hypertension.
boolean
C0745133 (UMLS CUI [1])
C0235222 (UMLS CUI [2,1])
C0205409 (UMLS CUI [2,2])
Body mass index
Item
body-mass index ≥ 40kg/m2.
boolean
C1305855 (UMLS CUI [1])
Anatomy of renal artery Suboptimal Renal artery denervation
Item
the anatomy of the renal arteries is suboptimal for renal denervation.
boolean
C0700276 (UMLS CUI [1,1])
C0035065 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C3544270 (UMLS CUI [1,4])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Mental disorders
Item
alcohol or substance abuse or psychiatric illnesses.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in other study.
boolean
C2348568 (UMLS CUI [1])
Contextual factors Clinical Suboptimal Renal artery denervation
Item
the clinical context is suboptimal for renal denervation.
boolean
C0542559 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C3544270 (UMLS CUI [1,4])
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