ID

40031

Description

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01438229

Link

https://clinicaltrials.gov/show/NCT01438229

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 NCT01438229

English

Eligibility Hypertension NCT01438229

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
office systolic blood pressure that remains ≥160 mmhg (≥150 mmhg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
Description

Systolic Pressure | Diabetes Mellitus, Non-Insulin-Dependent | Antihypertensive Agents Quantity | Antihypertensive Agents Maximum Tolerated Dose Stable | Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0752079
UMLS CUI [4,3]
C0205360
UMLS CUI [5]
C0012798
age ≥18 and ≤80 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
able and willing to provide written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
able and willing to comply with the required follow-up schedule
Description

Compliance Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior renal artery intervention (balloon angioplasty or stenting)
Description

Renal artery Intervention | Angioplasty, Balloon | Stenting

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0184661
UMLS CUI [2]
C0002996
UMLS CUI [3]
C2348535
evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
Description

Atherosclerosis of renal artery

Data type

boolean

Alias
UMLS CUI [1]
C0155734
multiple main renal arteries in either kidney
Description

Renal artery Main Multiple | Kidney Either

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0439064
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C3844638
main renal arteries <4 mm in diameter or <20 mm in length
Description

Renal artery Main Diameter | Renal artery Main Length

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1301886
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1444754
egfr of <45 ml/min per 1.73 m2 using the mdrd formula
Description

GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C2170215
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
Description

Hypertension, Renovascular | Hypertensive disease Secondary to Kidney Diseases | Glomerulonephritis | Polycystic Kidney Diseases | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0020545
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0022658
UMLS CUI [3]
C0017658
UMLS CUI [4]
C0022680
UMLS CUI [5]
C0022661
others
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Hypertension NCT01438229

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure | Diabetes Mellitus, Non-Insulin-Dependent | Antihypertensive Agents Quantity | Antihypertensive Agents Maximum Tolerated Dose Stable | Diuretics
Item
office systolic blood pressure that remains ≥160 mmhg (≥150 mmhg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
boolean
C0871470 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0012798 (UMLS CUI [5])
Age
Item
age ≥18 and ≤80 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able and willing to provide written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Compliance Follow-up
Item
able and willing to comply with the required follow-up schedule
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Renal artery Intervention | Angioplasty, Balloon | Stenting
Item
prior renal artery intervention (balloon angioplasty or stenting)
boolean
C0035065 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
Atherosclerosis of renal artery
Item
evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
boolean
C0155734 (UMLS CUI [1])
Renal artery Main Multiple | Kidney Either
Item
multiple main renal arteries in either kidney
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0022646 (UMLS CUI [2,1])
C3844638 (UMLS CUI [2,2])
Renal artery Main Diameter | Renal artery Main Length
Item
main renal arteries <4 mm in diameter or <20 mm in length
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0035065 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
GFR estimation by MDRD
Item
egfr of <45 ml/min per 1.73 m2 using the mdrd formula
boolean
C2170215 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypertension, Renovascular | Hypertensive disease Secondary to Kidney Diseases | Glomerulonephritis | Polycystic Kidney Diseases | Kidney Failure, Chronic
Item
renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
boolean
C0020545 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0022658 (UMLS CUI [2,3])
C0017658 (UMLS CUI [3])
C0022680 (UMLS CUI [4])
C0022661 (UMLS CUI [5])
Exclusion Criteria Additional
Item
others
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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