ID

42122

Description

Single-arm Study of Symplicity™ Renal Denervation System in Patients With Uncontrolled HyperTensioN in India; ODM derived from: https://clinicaltrials.gov/show/NCT01632943

Link

https://clinicaltrials.gov/show/NCT01632943

Keywords

  1. 4/22/16 4/22/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 11/17/21 11/17/21 -
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Adults With Uncontrolled Hypertension NCT01632943

Eligibility Adults With Uncontrolled Hypertension NCT01632943

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individual is 18 and 80 years old at time of treatment.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
Description

anti-hypertensive medications

Data type

boolean

Alias
UMLS CUI [1]
C0003364
individual has an office systolic blood pressure of 160 mm hg based on an average of 3 blood pressure readings measured at screening visits
Description

systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
main renal arteries with less than 4 mm diameter or with less than 20 mm treatable length
Description

main renal arteries

Data type

boolean

Alias
UMLS CUI [1]
C0340806
multiple renal arteries where the main renal artery is estimated to supply less than 75 percent of the kidney.
Description

multiple renal arteries

Data type

boolean

Alias
UMLS CUI [1]
C0265949
renal artery stenosis more than 50 percent or renal artery aneurysm in either renal artery.
Description

renal artery stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0035067
a history of prior renal artery intervention including balloon angioplasty or stenting.
Description

renal artery intervention

Data type

boolean

Alias
UMLS CUI [1]
C1322812
UMLS CUI [2]
C0455727
individual has an estimated glomerular filtration rate of less than 45ml per min per 1.73m2, using the mdrd calculation.
Description

estimated glomerular filtration rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
Description

hypertensive crisis

Data type

boolean

Alias
UMLS CUI [1]
C0020546
individual has type 1 diabetes mellitus.
Description

diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
Description

symptomatic orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0740482
individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Description

chronic oxygen support

Data type

boolean

Alias
UMLS CUI [1]
C3872899
individual has primary pulmonary hypertension.
Description

primary pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C3203102
individual has known secondary causes of hypertension, such as untreated pheochromocytoma, cushing's disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
Description

myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0002965
UMLS CUI [2]
C0039070
individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
Description

cardiovascular intervention

Data type

boolean

Alias
UMLS CUI [1]
C0038897
individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol specified automatic blood pressure monitor
Description

accurate blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated.
Description

cardiac valve stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0264878
individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
(C0009488
individual is pregnant, nursing or planning to be pregnant.
Description

pregnant, nursing

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Description

history of drug use or alcohol dependency

Data type

boolean

Alias
UMLS CUI [1]
C0038586
individual is currently enrolled in another investigational drug or device trial. for the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
Description

enrolled in another investigational drug or device trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Adults With Uncontrolled Hypertension NCT01632943

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
individual is 18 and 80 years old at time of treatment.
boolean
C0001779 (UMLS CUI [1])
anti-hypertensive medications
Item
individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
boolean
C0003364 (UMLS CUI [1])
systolic blood pressure
Item
individual has an office systolic blood pressure of 160 mm hg based on an average of 3 blood pressure readings measured at screening visits
boolean
C0871470 (UMLS CUI [1])
informed consent
Item
individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
main renal arteries
Item
main renal arteries with less than 4 mm diameter or with less than 20 mm treatable length
boolean
C0340806 (UMLS CUI [1])
multiple renal arteries
Item
multiple renal arteries where the main renal artery is estimated to supply less than 75 percent of the kidney.
boolean
C0265949 (UMLS CUI [1])
renal artery stenosis
Item
renal artery stenosis more than 50 percent or renal artery aneurysm in either renal artery.
boolean
C0035067 (UMLS CUI [1])
renal artery intervention
Item
a history of prior renal artery intervention including balloon angioplasty or stenting.
boolean
C1322812 (UMLS CUI [1])
C0455727 (UMLS CUI [2])
estimated glomerular filtration rate
Item
individual has an estimated glomerular filtration rate of less than 45ml per min per 1.73m2, using the mdrd calculation.
boolean
C3811844 (UMLS CUI [1])
hypertensive crisis
Item
individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
boolean
C0020546 (UMLS CUI [1])
diabetes mellitus
Item
individual has type 1 diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
symptomatic orthostatic hypotension
Item
individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
boolean
C0740482 (UMLS CUI [1])
chronic oxygen support
Item
individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
boolean
C3872899 (UMLS CUI [1])
primary pulmonary hypertension
Item
individual has primary pulmonary hypertension.
boolean
C3203102 (UMLS CUI [1])
Secondary hypertension
Item
individual has known secondary causes of hypertension, such as untreated pheochromocytoma, cushing's disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
boolean
C0155616 (UMLS CUI [1])
myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident
Item
individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
boolean
C0027051 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0039070 (UMLS CUI [2])
cardiovascular intervention
Item
individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
boolean
C0038897 (UMLS CUI [1])
accurate blood pressure
Item
individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol specified automatic blood pressure monitor
boolean
C0005823 (UMLS CUI [1])
cardiac valve stenosis
Item
individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated.
boolean
C0264878 (UMLS CUI [1])
Protocol Compliance
Item
individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
boolean
C0525058 (UMLS CUI [1])
(C0009488 (UMLS CUI [2])
pregnant, nursing
Item
individual is pregnant, nursing or planning to be pregnant.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
history of drug use or alcohol dependency
Item
individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
boolean
C0038586 (UMLS CUI [1])
enrolled in another investigational drug or device trial
Item
individual is currently enrolled in another investigational drug or device trial. for the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
boolean
C2348568 (UMLS CUI [1])

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