ID

36120

Description

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

Lien

https://clinicaltrials.gov/show/NCT02029885

Mots-clés

Versions (1)
  1. 15/04/2019 15/04/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

15 avril 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT02029885

Anglais

Eligibility Hypertension NCT02029885

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

Systolic Pressure Average

Type de données

boolean

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

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

Type de données

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.
Description

Change of medication Absent

Type de données

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:
Description

Antihypertensive Agents Quantity | Diuretics Quantity | Dosage Criteria Fulfill

Type de données

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;
Description

Dose Drug Labeled Highest

Type de données

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;
Description

Dose Usual Highest

Type de données

boolean

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

Maximum Tolerated Dose

Type de données

boolean

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

Dose Appropriate Highest

Type de données

boolean

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

Kidney Functioning Quantity

Type de données

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).
Description

Renal function GFR estimation by MDRD

Type de données

boolean

Alias
UMLS CUI [1]
C2170215
Exclusion Criteria
Description

Exclusion Criteria

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

Secondary hypertension

Type de données

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
Description

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

Type de données

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
Description

Kidney Calculi Size Location | Kidney Calculi Interfere with Therapeutic procedure

Type de données

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
Description

Operation on abdominal region

Type de données

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.
Description

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

Type de données

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.
Description

Heart valve disease Stenotic | Blood Pressure Reduction At risk

Type de données

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.
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Type de données

boolean

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

Primary pulmonary hypertension Severe

Type de données

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.
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Type de données

boolean

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

Heart valve disease Hemodynamic Significant

Type de données

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
Description

Body mass index

Type de données

boolean

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

Targeted Therapy Depth

Type de données

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.
Description

Anatomy aspects Exclude Therapeutic procedure Specified | Other Coding

Type de données

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.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Type de données

boolean

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

Study Subject Participation Status Interferes with Research

Type de données

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.
Description

Condition Study Subject Participation Status Excluded

Type de données

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
Description

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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