ID

36120

Beskrivning

Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02029885

Länk

https://clinicaltrials.gov/show/NCT02029885

Nyckelord

Versioner (1)
  1. 2019-04-15 2019-04-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02029885

Engelsk

Eligibility Hypertension NCT02029885

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is at least 18 years of age and no more than 90 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. average sbp ≥ 160 mmhg
Beskrivning

Systolic Pressure Average

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1510992
3. 24 hour average abpm daytime sbp ≥ 135 mmhg.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2022220
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332169
4. no medication changes for a minimum of 1 months prior to screening.
Beskrivning

Change of medication Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0332197
5. at minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
Beskrivning

Antihypertensive Agents Quantity | Diuretics Quantity | Dosage Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0012798
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0243161
UMLS CUI [3,3]
C1550543
1. highest labeled dose according to medication's labeling;
Beskrivning

Dose Drug Labeled Highest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0013191
UMLS CUI [1,3]
C1522410
2. highest usual dose per clinical guidelines jnc-7;
Beskrivning

Dose Usual Highest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C3538928
UMLS CUI [1,3]
C1522410
3. highest tolerated dose; and/or
Beskrivning

Maximum Tolerated Dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0752079
4. highest appropriate dose for the subject per the pi's clinical judgment.
Beskrivning

Dose Appropriate Highest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1522410
6. subject has two functioning kidneys.
Beskrivning

Kidney Functioning Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C1265611
7. subject has an egfr value of ≥ 30 ml/min/1.73 m² (mdrd formula).
Beskrivning

Renal function GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C2170215
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has any secondary cause of hypertension
Beskrivning

Secondary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
2. subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and doppler analysis on ultrasound
Beskrivning

Renal Artery Stenosis Flow Rate | Renal Artery Stenosis Arterial velocity | Renal Artery Stenosis Doppler ultrasonography of artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C2826285
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C0429859
UMLS CUI [3,1]
C0035067
UMLS CUI [3,2]
C2021508
3. subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
Beskrivning

Kidney Calculi Size Location | Kidney Calculi Interfere with Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022650
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C0022650
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0087111
4. subject has a history of intra-abdominal surgery within the past six months
Beskrivning

Operation on abdominal region

Datatyp

boolean

Alias
UMLS CUI [1]
C0198482
5. subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
Beskrivning

Kidney Heterogeneity Interferes with Therapeutic procedure | Cysts Large | Tumors Large

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0019409
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0010709
UMLS CUI [2,2]
C0549177
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0549177
6. stenotic valvular heart disease for which bp reduction would be hazardous as determined by referring physician.
Beskrivning

Heart valve disease Stenotic | Blood Pressure Reduction At risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0333181
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C1293152
UMLS CUI [2,3]
C1444641
7. mi, unstable angina, or cva in the prior 6 months.
Beskrivning

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
8. known severe primary pulmonary htn
Beskrivning

Primary pulmonary hypertension Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152171
UMLS CUI [1,2]
C0205082
9. subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
Beskrivning

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
10. subject has hemodynamically significant valvular heart disease.
Beskrivning

Heart valve disease Hemodynamic Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
11. subject has bmi over 40 km/m^2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
12. subject has a target treatment depth over 13 cm.
Beskrivning

Targeted Therapy Depth

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0205125
13. subject has anatomy that precludes treatment with the kona medical surround sound system.
Beskrivning

Anatomy aspects Exclude Therapeutic procedure Specified | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1384516
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205369
UMLS CUI [2]
C3846158
14. subject is pregnant, nursing, or intends to become pregnant during the trial period.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
15. subject is currently enrolled in other potentially confounding research.
Beskrivning

Study Subject Participation Status Interferes with Research

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0035168
16. subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Beskrivning

Condition Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
17. subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
Beskrivning

Clinical Study Follow-up Compliance Unable | Clinical Study Follow-up Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Hypertension NCT02029885

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is at least 18 years of age and no more than 90 years of age
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure Average
Item
2. average sbp ≥ 160 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
24-hour ambulatory blood pressure monitoring Average | Systolic Pressure Daytime
Item
3. 24 hour average abpm daytime sbp ≥ 135 mmhg.
boolean
C2022220 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332169 (UMLS CUI [2,2])
Change of medication Absent
Item
4. no medication changes for a minimum of 1 months prior to screening.
boolean
C0580105 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antihypertensive Agents Quantity | Diuretics Quantity | Dosage Criteria Fulfill
Item
5. at minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
Dose Drug Labeled Highest
Item
1. highest labeled dose according to medication's labeling;
boolean
C0178602 (UMLS CUI [1,1])
C0013191 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Dose Usual Highest
Item
2. highest usual dose per clinical guidelines jnc-7;
boolean
C0178602 (UMLS CUI [1,1])
C3538928 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Maximum Tolerated Dose
Item
3. highest tolerated dose; and/or
boolean
C0752079 (UMLS CUI [1])
Dose Appropriate Highest
Item
4. highest appropriate dose for the subject per the pi's clinical judgment.
boolean
C0178602 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Kidney Functioning Quantity
Item
6. subject has two functioning kidneys.
boolean
C0022646 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Renal function GFR estimation by MDRD
Item
7. subject has an egfr value of ≥ 30 ml/min/1.73 m² (mdrd formula).
boolean
C2170215 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
1. subject has any secondary cause of hypertension
boolean
C0155616 (UMLS CUI [1])
Renal Artery Stenosis Flow Rate | Renal Artery Stenosis Arterial velocity | Renal Artery Stenosis Doppler ultrasonography of artery
Item
2. subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and doppler analysis on ultrasound
boolean
C0035067 (UMLS CUI [1,1])
C2826285 (UMLS CUI [1,2])
C0035067 (UMLS CUI [2,1])
C0429859 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3,1])
C2021508 (UMLS CUI [3,2])
Kidney Calculi Size Location | Kidney Calculi Interfere with Therapeutic procedure
Item
3. subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
boolean
C0022650 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0022650 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Operation on abdominal region
Item
4. subject has a history of intra-abdominal surgery within the past six months
boolean
C0198482 (UMLS CUI [1])
Kidney Heterogeneity Interferes with Therapeutic procedure | Cysts Large | Tumors Large
Item
5. subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
boolean
C0022646 (UMLS CUI [1,1])
C0019409 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0010709 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0549177 (UMLS CUI [3,2])
Heart valve disease Stenotic | Blood Pressure Reduction At risk
Item
6. stenotic valvular heart disease for which bp reduction would be hazardous as determined by referring physician.
boolean
C0018824 (UMLS CUI [1,1])
C0333181 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C1293152 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
7. mi, unstable angina, or cva in the prior 6 months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Primary pulmonary hypertension Severe
Item
8. known severe primary pulmonary htn
boolean
C0152171 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
9. subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Heart valve disease Hemodynamic Significant
Item
10. subject has hemodynamically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Body mass index
Item
11. subject has bmi over 40 km/m^2
boolean
C1305855 (UMLS CUI [1])
Targeted Therapy Depth
Item
12. subject has a target treatment depth over 13 cm.
boolean
C2985566 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Anatomy aspects Exclude Therapeutic procedure Specified | Other Coding
Item
13. subject has anatomy that precludes treatment with the kona medical surround sound system.
boolean
C1384516 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
14. subject is pregnant, nursing, or intends to become pregnant during the trial period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status Interferes with Research
Item
15. subject is currently enrolled in other potentially confounding research.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Condition Study Subject Participation Status Excluded
Item
16. subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Clinical Study Follow-up Compliance Unable | Clinical Study Follow-up Compliance Unwilling
Item
17. subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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