ID

40035

Description

Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01499810

Link

https://clinicaltrials.gov/show/NCT01499810

Keywords

Versions (1)
  1. 3/10/20 3/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01499810

English

Eligibility Hypertension NCT01499810

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 and ≤ 80 years at time of randomization
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
Description

Antihypertensive Agents Quantity Dose Full | Antihypertensive Agents Class Different | Diuretics Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0443225
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C1265611
office systolic bp (sbp) ≥ 160 mmhg or diastolic bp (dbp) ≥ 100 mmhg
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73 m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
ambulatory blood pressure monitoring (abpm) 24 hour average sbp < 135 mmhg or dbp < 85 mmhg
Description

24-hour ambulatory blood pressure monitoring Average | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C2022220
UMLS CUI [1,2]
C1510992
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
symptomatic(secondary) hypertension
Description

Secondary hypertension Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0231220
severe renal artery stenosis or renal arteries abnormalities
Description

Renal Artery Stenosis Severe | Abnormality of the renal artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C4024624
individual is pregnant, nursing or planning to be pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
severe hepatic dysfunction
Description

Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
Description

Kidney Diseases | Hematological Disease | Metabolic Diseases | Nervous system disorder | Gastrointestinal Diseases | Liver diseases | Lung diseases | Dysfunction Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0025517
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0024115
UMLS CUI [8,1]
C3887504
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C0332196
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Similar models

Eligibility Hypertension NCT01499810

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 and ≤ 80 years at time of randomization
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Antihypertensive Agents Quantity Dose Full | Antihypertensive Agents Class Different | Diuretics Quantity
Item
treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0443225 (UMLS CUI [1,4])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Systolic Pressure | Diastolic blood pressure
Item
office systolic bp (sbp) ≥ 160 mmhg or diastolic bp (dbp) ≥ 100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
an estimated glomerular filtration rate (egfr) of < 30 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
24-hour ambulatory blood pressure monitoring Average | Systolic Pressure | Diastolic blood pressure
Item
ambulatory blood pressure monitoring (abpm) 24 hour average sbp < 135 mmhg or dbp < 85 mmhg
boolean
C2022220 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Secondary hypertension Symptomatic
Item
symptomatic(secondary) hypertension
boolean
C0155616 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Renal Artery Stenosis Severe | Abnormality of the renal artery
Item
severe renal artery stenosis or renal arteries abnormalities
boolean
C0035067 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4024624 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
individual is pregnant, nursing or planning to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Liver Dysfunction Severe
Item
severe hepatic dysfunction
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Diseases | Hematological Disease | Metabolic Diseases | Nervous system disorder | Gastrointestinal Diseases | Liver diseases | Lung diseases | Dysfunction Study Subject Participation Status Excluded
Item
any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
boolean
C0022658 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C3887504 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C0332196 (UMLS CUI [8,3])
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