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

Not Applicable

Completed

• Conditions: End-stage Renal Disease; Hypertension
• Interventions: Procedure: Renal Denervation

• Registration Number: NCT02021019
• Lead Sponsor: Baker Heart and Diabetes Institute

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 available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Study Start: 2014-01
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation	Renal denervation using a catheter-based Radio-frequency approach

Primary Outcome Measures

Name	Time	Method
Blood Pressure change	6 months	Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure

Trial Locations

Locations (1)

Baker IDI Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia