Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Systolic blood pressure of 160 mmHg or greater
On 3 or more antihypertensive medications
On dialysis for more than 6 months

Exclusion criteria

Renal artery abnormalities
Known secondary hypertension attributable to a cause other than sleep apnea
MI, angina, CVA within 6 months
Others

Treatment and study plan

Renal Denervation with a catheter-based procedure

Device

Disruption of the renal nerves with a catheter-based procedure

Primary outcomes

Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

Time frame: Through 1 year

Secondary outcomes

Physiologic response to denervation (e.g., blood pressure reduction)

Time frame: Through 1 year

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Sep 16, 2008
Registry last updated: Nov 6, 2012

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