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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02021019
Registration number
NCT02021019
Ethics application status
Date submitted
16/12/2013
Date registered
27/12/2013
Date last updated
14/09/2023
Titles & IDs
Public title
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
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Scientific title
Renal Denervation to Improve Outcomes in Patients With End-stage Renal
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Secondary ID [1]
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1052470
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Secondary ID [2]
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527/13
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End-stage Renal Disease
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Hypertension
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Renal Denervation
Experimental: Renal Denervation - Renal denervation using a catheter-based Radio-frequency approach
No intervention: Usual Care - Usual care
Treatment: Surgery: Renal Denervation
Renal Denervation
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Blood Pressure change
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Assessment method [1]
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Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
* end stage renal disease
* hypertension (BP=140/90mmHg)
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
* Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2022
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Sample size
Target
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker IDI Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.
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Trial website
https://clinicaltrials.gov/study/NCT02021019
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Markus P Schlaich, MD
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Address
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Baker Heart and Diabetes Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02021019
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