Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-12-31
2015-04-30
Brief Summary
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Detailed Description
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Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.
A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.
The duration of this study is 36 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual care
participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets
No interventions assigned to this group
Renal Denervation Group
participants randomised to undergo the renal denervation procedure
Renal Denervation
Renal Denervation Catheter
Interventions
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Renal Denervation
Renal Denervation Catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* concurrent treatment with 2 anti-hypertensive drugs
Exclusion Criteria
* eGFR \<15mL/min/1.73m2 (using MDRD formula)
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of child bearing potential must have negative pregnancy test prior to treatment
18 Years
85 Years
ALL
No
Sponsors
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Baker Heart and Diabetes Institute
OTHER
Responsible Party
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Principal Investigators
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Markus P Schlaich, MD
Role: PRINCIPAL_INVESTIGATOR
Baker IDI Heart & Diabetes Institute
Other Identifiers
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1034397
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
070/12
Identifier Type: -
Identifier Source: org_study_id
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