ID

40318

Description

Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4; ODM derived from: https://clinicaltrials.gov/show/NCT01972139

Link

https://clinicaltrials.gov/show/NCT01972139

Keywords

Versions (1)
  1. 4/7/20 4/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01972139

English

Eligibility Hypertension NCT01972139

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individual is on maximally tolerated stable medication regimen including 3 or more anti-ive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
Description

Pharmacotherapy Maximum Tolerated Dose Stable | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Thiazides Quantity | Thiazide Diuretics Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0752079
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0456387
UMLS CUI [3,3]
C1705242
UMLS CUI [4,1]
C0541746
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0012802
UMLS CUI [5,2]
C1265611
individual has office sbp greater than or equal to 140mmhg and less than 160mmhg
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
individual has abpm average sbp greater than or equal to 135 mmhg
Description

Ambulatory Blood Pressure Monitoring Average Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C1510992
UMLS CUI [1,3]
C0871470
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individual lacks appropriate renal artery anatomy
Description

Renal artery Anatomy Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1548788
individual has egfr of less than 30
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
individual has type i diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
individual has had one or more episodes of orthostatic hypotension
Description

Episode Quantity Orthostatic Hypotension

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020651
individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
Description

Patient need for Oxygen therapy support chronic | Exception Respiration Support Sleep Apnea

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3872899
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0035203
UMLS CUI [2,3]
C1521721
UMLS CUI [2,4]
C0037315
individual has primary pulmonary hypertension
Description

Idiopathic pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
individual has other concomitant conditions that may adversely affect the patient or the study outcomes
Description

Comorbidity At risk Patient | Comorbidity Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
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
individual has had a previous organ transplant
Description

Organ Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205156
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Similar models

Eligibility Hypertension NCT01972139

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pharmacotherapy Maximum Tolerated Dose Stable | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Thiazides Quantity | Thiazide Diuretics Quantity
Item
individual is on maximally tolerated stable medication regimen including 3 or more anti-ive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
boolean
C0013216 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C0541746 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0012802 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Systolic Pressure
Item
individual has office sbp greater than or equal to 140mmhg and less than 160mmhg
boolean
C0871470 (UMLS CUI [1])
Ambulatory Blood Pressure Monitoring Average Systolic Pressure
Item
individual has abpm average sbp greater than or equal to 135 mmhg
boolean
C0242876 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Renal artery Anatomy Inappropriate
Item
individual lacks appropriate renal artery anatomy
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
individual has egfr of less than 30
boolean
C3811844 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
individual has type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Episode Quantity Orthostatic Hypotension
Item
individual has had one or more episodes of orthostatic hypotension
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,3])
Patient need for Oxygen therapy support chronic | Exception Respiration Support Sleep Apnea
Item
individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
boolean
C0686904 (UMLS CUI [1,1])
C3872899 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0035203 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
C0037315 (UMLS CUI [2,4])
Idiopathic pulmonary hypertension
Item
individual has primary pulmonary hypertension
boolean
C0152171 (UMLS CUI [1])
Comorbidity At risk Patient | Comorbidity Interferes with Research results
Item
individual has other concomitant conditions that may adversely affect the patient or the study outcomes
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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])
Organ Transplantation Previous
Item
individual has had a previous organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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