ID

36134

Description

Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE); ODM derived from: https://clinicaltrials.gov/show/NCT02392351

Link

https://clinicaltrials.gov/show/NCT02392351

Keywords

Versions (1)
  1. 4/17/19 4/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT02392351

English

Eligibility Hypertension NCT02392351

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 and ≤75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
osbp ≥150 mmhg and ≤180 mmhg based on an average of 3 office-based blood pressure measurements
Description

Office Blood pressure determination | Average Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C0005824
UMLS CUI [2,1]
C1510992
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C1265611
average 24-hour asbp ≥135 mmhg and ≤170 mmhg
Description

Average 24 hour blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C1282173
for each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
Description

Kidney Each | Renal artery Main Diameter | Renal artery Main Length | Accessory renal arteries | Accessory renal arteries Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C1457900
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0035065
UMLS CUI [3,2]
C1542147
UMLS CUI [3,3]
C1444754
UMLS CUI [4]
C0226335
UMLS CUI [5,1]
C0226335
UMLS CUI [5,2]
C0332197
agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stenosis >30% or renal artery aneurysm in either renal artery
Description

Stenosis Percentage | Aneurysm of renal artery

Data type

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0439165
UMLS CUI [2]
C0155742
fibromuscular dysplasia (fmd)
Description

Fibromuscular Dysplasia

Data type

boolean

Alias
UMLS CUI [1]
C0016052
known causes of secondary htn
Description

Cause Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0155616
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
egfr <40 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
Description

Cardiac ejection fraction | Hospitalization Due to Heart Failure

Data type

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C3898876
severe valvular heart disease
Description

Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of sbp of ≥20 mmhg or dbp of ≥10 mmhg within three minutes of standing) coupled with symptoms within the past year or during screening
Description

Episode of Orthostatic Hypotension Associated with Symptoms | Independent of Change of medication | Standing systolic blood pressure Reduced | Standing diastolic blood pressure Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0020651
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C1457887
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0580105
UMLS CUI [3,1]
C1303018
UMLS CUI [3,2]
C0392756
UMLS CUI [4,1]
C1303019
UMLS CUI [4,2]
C0392756
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Similar models

Eligibility Hypertension NCT02392351

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 and ≤75 years
boolean
C0001779 (UMLS CUI [1])
Office Blood pressure determination | Average Measurement Quantity
Item
osbp ≥150 mmhg and ≤180 mmhg based on an average of 3 office-based blood pressure measurements
boolean
C0442603 (UMLS CUI [1,1])
C0005824 (UMLS CUI [1,2])
C1510992 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Average 24 hour blood pressure
Item
average 24-hour asbp ≥135 mmhg and ≤170 mmhg
boolean
C1510992 (UMLS CUI [1,1])
C1282173 (UMLS CUI [1,2])
Kidney Each | Renal artery Main Diameter | Renal artery Main Length | Accessory renal arteries | Accessory renal arteries Absent
Item
for each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
boolean
C0022646 (UMLS CUI [1,1])
C1457900 (UMLS CUI [1,2])
C0035065 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0035065 (UMLS CUI [3,1])
C1542147 (UMLS CUI [3,2])
C1444754 (UMLS CUI [3,3])
C0226335 (UMLS CUI [4])
C0226335 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Protocol Compliance | Informed Consent
Item
agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Stenosis Percentage | Aneurysm of renal artery
Item
stenosis >30% or renal artery aneurysm in either renal artery
boolean
C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0155742 (UMLS CUI [2])
Fibromuscular Dysplasia
Item
fibromuscular dysplasia (fmd)
boolean
C0016052 (UMLS CUI [1])
Cause Secondary hypertension
Item
known causes of secondary htn
boolean
C0015127 (UMLS CUI [1,1])
C0155616 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr <40 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Cardiac ejection fraction | Hospitalization Due to Heart Failure
Item
known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
boolean
C0232174 (UMLS CUI [1])
C3898876 (UMLS CUI [2])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Episode of Orthostatic Hypotension Associated with Symptoms | Independent of Change of medication | Standing systolic blood pressure Reduced | Standing diastolic blood pressure Reduced
Item
≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of sbp of ≥20 mmhg or dbp of ≥10 mmhg within three minutes of standing) coupled with symptoms within the past year or during screening
boolean
C0332189 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0332291 (UMLS CUI [2,1])
C0580105 (UMLS CUI [2,2])
C1303018 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C1303019 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
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