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

NCT02021019 | Completed

• 2 other identifiers: 527/131052470
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Renal denervation using a catheter-based Radio-frequency approach

Procedure: Renal Denervation

Usual Care

NO INTERVENTION

Usual care

Interventions

Renal Denervation PROCEDURE

Renal Denervation

Also known as: Symplicity Renal Denervation Catheter

Renal Denervation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Markus P Schlaich, MD

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 27, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

AU (1)