Renal Denervation in Patients With Chronic Kidney Disease

NCT01832233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-01-22

No results posted yet for this study

Summary

People with hypertension are at a higher risk for cardiovascular disease and death so it is important to lower blood pressure to normal levels as quickly as possible. Previous research has established that renal nerve denervation successfully lowers blood pressure measured in the arm in the physician's office. This study is being conducted so that the investigators can determine whether renal nerve denervation also helps to lower blood pressure over 24 hours, as well as central aortic blood pressure, which is pressure exerted by the aorta closer to the heart and may be a better predictor of cardiovascular problems. The investigators also want to know whether these beneficial effects on blood pressure can last up to 2 years, whether renal denervation reduces the number of medications patients need to take, and whether it reduces glucose and insulin levels in the blood since hypertension is also related to obesity and diabetes.

Conditions

Interventions

PROCEDURE

Renal Denervation

The Symplicity Renal Denervation System is indicated for the delivery of low-level radiofrequency energy through the wall of the renal artery to denervate the kidney and reduce blood pressure in adult patients with refractory hypertension. The Symplicity Generator delivers controlled relatively low power radiofrequency energy (approximately 8 watts for 2 minutes). The Symplicity System selectively denervates the kidney by delivering radiofrequency from the generator via the electrode of the catheter through the renal artery wall from the intra-luminal side to ablate the renal sympathetic efferent and afferent nerves and reduce overall sympathetic nervous system activity.

Sponsors & Collaborators

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Bhanu Prasad, MD · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832233 on ClinicalTrials.gov