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ID
42122
Beschrijving
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
Trefwoorden
Versies (3)
- 22-04-16 22-04-16 -
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
- 17-11-21 17-11-21 -
Geüploaded op
13 april 2021
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Adults With Uncontrolled Hypertension NCT01632943
Eligibility Adults With Uncontrolled Hypertension NCT01632943
- StudyEvent: Eligibility
Similar models
Eligibility Adults With Uncontrolled Hypertension NCT01632943
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
(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])
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])