Overview

This trial is active, not recruiting.

Conditions end-stage renal disease, hypertension
Treatment renal denervation
Sponsor Baker IDI Heart and Diabetes Institute
Start date January 2014
End date December 2016
Trial size 100 participants
Trial identifier NCT02021019, 1052470, 527/13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Renal denervation using a catheter-based Radio-frequency approach
renal denervation Symplicity Renal Denervation Catheter
Renal Denervation
(No Intervention)
Usual care

Primary Outcomes

Measure
Blood Pressure change
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Renal Denervation to Improve Outcomes in Patients With End-stage Renal
Principal investigator Markus P Schlaich, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Baker IDI Heart and Diabetes Institute.