Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease Using a Novel Non-iodinated Contrast Free Protocol

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Disease
• Intervention / Treatment: Device: Renal Sympathetic Denervation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B9 5SS
      • Heart of England NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation; Participation receiving renal sympathetic denervation	Device: Renal Sympathetic Denervation; Renal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heart of England NHS Trust
• Investigators: Principal Investigator: Indranil Dasgupta, DM, Heart of England NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Uncontrolled hypertension; Renal sympathetic denervation; Carbon dioxide angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2012138RN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO