Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
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ClinicalTrials.gov Identifier: NCT02021019 |
Recruitment Status :
Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : November 5, 2018
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Condition or disease | Intervention/treatment | Phase |
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End-stage Renal Disease Hypertension | Procedure: Renal Denervation | Not Applicable |
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 |

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

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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 |
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.

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
Australia, Victoria | |
Baker IDI Heart and Diabetes Institute | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Markus P Schlaich, MD | Baker Heart and Diabetes Institute |
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 |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |