Renal Denervation in Patients With Chronic Kidney Disease

NCT01832233 | Completed

• 1 other identifier: REB12-73
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Central Blood Pressure at 6-months Post-Renal Denervation

  measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  Baseline to 6 months after treatment

Secondary Outcomes (17)

• Change from Baseline in fasting glucose

  Baseline, Post 3, 6, 12, 18, 24 months after renal denervation treatment

• Change from Baseline in Cardiac Parameters

  Baseline, Post 12 and 24 months renal denervation treatment

• Change from Baseline in fasting insulin

  Baseline, Post 3, 6, 12, 18, 24 months after renal denervation treatment.

• Change from Baseline in Peripheral Blood Pressure at 3 months Post-Renal Denervation

  Baseline to 3 months after treatment

• Change from Baseline in Peripheral Blood Pressure at 6 months Post-Renal Denervation

  Baseline to 6 months after treatment

Study Arms (1)

Renal Denervation

EXPERIMENTAL

Patients with resistant hypertension and chronic kidney disease (GFR between 15 and 60) will receive Renal Denervation as a treatment

Procedure: Renal Denervation

Interventions

Renal Denervation PROCEDURE

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.

Renal Denervation

Eligibility Criteria

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

You may qualify if:

• Glomerular filtration rate: 60-15 mls/min as per the modified diet in renal disease formula (Stage 3 and 4 Chronic Kidney Disease)
• Daytime systolic blood pressure on ambulatory monitor ≥ 135 mm Hg while taking 3 or more anti-hypertensives including a diuretic on maximal dose OR ambulatory monitor systolic blood pressure is \<135 but taking 4 or more anti-hypertensives
• years and above
• A minimum of 20 mm of length and 4 mm of diameter for renal arteries on CT renal angiogram or formal renal angiogram

You may not qualify if:

• not suitable for renal denervation based on the Indications for Use

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Study Sites (1)

Regina Qu'Appelle Health Region

Regina, Saskatchewan, Canada

Location

Related Publications (2)

• Prasad B, Berry W, Goyal K, Dehghani P, Townsend RR. Central Blood Pressure and Pulse Wave Velocity Changes Post Renal Denervation in Patients With Stages 3 and 4 Chronic Kidney Disease: The Regina RDN Study. Can J Kidney Health Dis. 2019 Feb 13;6:2054358119828388. doi: 10.1177/2054358119828388. eCollection 2019.

  PMID: 30792873 DERIVED

• Prasad B, St Onge JR, McCarron MCE, Goyal K, Dehghani P. The Impact on Central Blood Pressure and Arterial Stiffness Post Renal Denervation in Patients With Stage 3 and 4 Chronic Kidney Disease: The Prairie Renal Denervation Study. Can J Kidney Health Dis. 2017 Jul 12;4:2054358117719028. doi: 10.1177/2054358117719028. eCollection 2017.

  PMID: 28835849 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Bhanu Prasad, MD

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 16, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)