ID

40354

Description

Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01887067

Link

https://clinicaltrials.gov/show/NCT01887067

Keywords

Versions (1)
  1. 4/11/20 4/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension, Resistant NCT01887067

English

Eligibility Hypertension, Resistant NCT01887067

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ranges from 18 to 70 years inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertension
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
office systolic bp (sbp) ≥ 150 mmhg or diastolic bp (dbp) ≥ 90mmhg
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
Description

Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretics | Intolerance to Pharmaceutical Preparations multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [3]
C0012798
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0439064
type 2 diabetes mellitus on oral hypoglycaemic agent (oha)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0359086
2 functional kidneys; egfr ≥ 45 ml/min/1.73m² (mdrd formula)
Description

Both kidneys Functional | GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1,1]
C0227665
UMLS CUI [1,2]
C0205245
UMLS CUI [2]
C2170215
suitable renal anatomy compatible with the endovascular denervation procedure
Description

Kidney Anatomy suitable Renal artery denervation | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C3544270
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individual has renal artery anatomy that is ineligible for treatment including:
Description

Renal artery Anatomy Ineligible Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
patients with secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
patient with type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
patient on insulin due to oral drug failure
Description

Insulin | Etiology Oral medication Failure

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0175795
UMLS CUI [2,3]
C0162643
renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
Description

Renal vascular disorder | Renal Artery Stenosis Severe | Renal stenting | Angioplasty renal artery | Renal arteries Dual

Data type

boolean

Alias
UMLS CUI [1]
C0268790
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1262325
UMLS CUI [4]
C1282893
UMLS CUI [5,1]
C0035065
UMLS CUI [5,2]
C0205173
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient with any implantable device incompatible with radiofrequency energy delivery
Description

Implant Inconsistent Radiofrequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0579006
hemodynamically significant valvular heart disease for which reduction of bp would be considered hazardous
Description

Heart valve disease Hemodynamic Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
Description

Medical condition Serious | Life Expectancy Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
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Similar models

Eligibility Hypertension, Resistant NCT01887067

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ranges from 18 to 70 years inclusive
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
essential hypertension
boolean
C0085580 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
office systolic bp (sbp) ≥ 150 mmhg or diastolic bp (dbp) ≥ 90mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretics | Intolerance to Pharmaceutical Preparations multiple
Item
3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0439064 (UMLS CUI [4,3])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic
Item
type 2 diabetes mellitus on oral hypoglycaemic agent (oha)
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Both kidneys Functional | GFR estimation by MDRD
Item
2 functional kidneys; egfr ≥ 45 ml/min/1.73m² (mdrd formula)
boolean
C0227665 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Kidney Anatomy suitable Renal artery denervation | Other Coding
Item
suitable renal anatomy compatible with the endovascular denervation procedure
boolean
C0022646 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C3544270 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Renal artery Anatomy Ineligible Therapy
Item
individual has renal artery anatomy that is ineligible for treatment including:
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Secondary hypertension
Item
patients with secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
patient with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin | Etiology Oral medication Failure
Item
patient on insulin due to oral drug failure
boolean
C0021641 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
C0162643 (UMLS CUI [2,3])
Renal vascular disorder | Renal Artery Stenosis Severe | Renal stenting | Angioplasty renal artery | Renal arteries Dual
Item
renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
boolean
C0268790 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1262325 (UMLS CUI [3])
C1282893 (UMLS CUI [4])
C0035065 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Implant Inconsistent Radiofrequency
Item
patient with any implantable device incompatible with radiofrequency energy delivery
boolean
C0021102 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0579006 (UMLS CUI [1,3])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease for which reduction of bp would be considered hazardous
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Medical condition Serious | Life Expectancy Limited
Item
any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
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