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Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021019
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Baker Heart and Diabetes Institute

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date November 5, 2018
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Blood Pressure change [ Time Frame: 6 months ]
Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
Official Title  ICMJE Renal Denervation to Improve Outcomes in Patients With End-stage Renal
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End-stage Renal Disease
  • Hypertension
Intervention  ICMJE Procedure: Renal Denervation
Renal Denervation
Other Name: Symplicity Renal Denervation Catheter
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Renal denervation using a catheter-based Radio-frequency approach
    Intervention: Procedure: Renal Denervation
  • No Intervention: Usual Care
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
100
Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • end stage renal disease
  • hypertension (BP≥140/90mmHg)

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021019
Other Study ID Numbers  ICMJE 527/13
1052470 ( Other Grant/Funding Number: NHMRC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baker Heart and Diabetes Institute
Study Sponsor  ICMJE Baker Heart and Diabetes Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus P Schlaich, MD Baker Heart and Diabetes Institute
PRS Account Baker Heart and Diabetes Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP