Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Sponsor

Heart of England NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02863510

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Chronic Kidney Disease	Device: Renal Sympathetic Denervation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.