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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; End-stage Renal Disease
• Intervention / Treatment: Procedure: Renal Denervation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Baker IDI Heart and Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care
Experimental: Renal Denervation; Renal denervation using a catheter-based Radio-frequency approach	Procedure: Renal Denervation; Renal Denervation; Other Names: Symplicity Renal Denervation Catheter

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Markus P Schlaich, MD, Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimated): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 527/13; 1052470 (Other Grant/Funding Number: NHMRC)