Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Chronic Kidney Disease

Intervention / Treatment
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* Device: Renal Sympathetic Denervation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Participation receiving renal sympathetic denervation | Device: Renal Sympathetic Denervation<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon dioxide angiography, Renal sympathetic denervation, Uncontrolled hypertension, Chronic kidney disease