Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863510
• Other study ID #: 2012138RN
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: August 8, 2017
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: Heart of England NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Foundation Trust	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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