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

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.

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Key information

Conditions

End-stage Renal Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Renal Denervation

Procedure

Renal Denervation

Other names: Symplicity Renal Denervation Catheter

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Dec 27, 2013
Registry last updated: Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed