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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Hypertension Procedure: Renal Denervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation to Improve Outcomes in Patients With End-stage Renal
Study Start Date : January 2014
Estimated Primary Completion Date : December 2022
Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Renal denervation using a catheter-based Radio-frequency approach
 Procedure: Renal Denervation
Renal Denervation
Other Name: Symplicity Renal Denervation Catheter
No Intervention: Usual Care
Usual care


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021019


Locations
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Australia, Victoria
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker Heart and Diabetes Institute
Investigators
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Principal Investigator: Markus P Schlaich, MD Baker Heart and Diabetes Institute
More Information
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Responsible Party: Baker Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT02021019    
Other Study ID Numbers: 527/13
1052470 ( Other Grant/Funding Number: NHMRC )
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency