Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Hypertension
• Interventions: Device: Renal Sympathetic Denervation

• Registration Number: NCT02863510
• Lead Sponsor: Heart of England NHS Trust

Brief Summary

A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.

Detailed Description

Renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)\>45 mL/min per 1•73 m². However, the safety and efficacy of this has not been studied in patients with more severe renal impairment. The investigators aim to examine safety and efficacy of renal denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. Moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. The investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. The investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2016-02-12
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients aged 18-75 years with a clinic systolic blood pressure of 140 mm Hg or more despite compliance with three or more antihypertensive drugs,
• eGFR<45 and >15 mL/min per 1.73 m².

Exclusion Criteria

• eGFR <15 mL/min per 1.73 m²,
• Type 1 diabetes,
• Substantial stenotic valvular heart disease,
• Pregnancy or planned pregnancy during the study,
• A history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Sympathetic Denervation	Participation receiving renal sympathetic denervation

Primary Outcome Measures

Name	Time	Method
Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days	at baseline, 7days and 30 days	Change in eGFR from baseline to 7 days and 1 month as measure of safety in terms of kidney function

Secondary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months	at baseline, 7 days, 1, 3, and 6 months	Change in kidney function from baseline to 7 days, 1, 3, and 6 months
Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.	at baseline, 1, 3, and 6 months	Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.
Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months	at baseline and 6 months	Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months
Change in office blood pressure from baseline to 1,3, and 6 months	at baseline, 1, 3, and 6 months	Change in office BP from baseline to 1,3, and 6 months for efficacy

Trial Locations

Locations (1)

Heart of England NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom