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Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Primary Purpose

Hypertension, Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Renal Sympathetic Denervation

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Carbon dioxide angiography, Renal sympathetic denervation, Uncontrolled hypertension, Chronic kidney disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Heart of England NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Denervation

Arm Description

Participation receiving renal sympathetic denervation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02863510

First Posted

February 12, 2016

Last Updated

August 8, 2017

Sponsor

Heart of England NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT02863510

Brief Title

Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Heart of England NHS Trust

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Chronic Kidney Disease

Keywords

Carbon dioxide angiography, Renal sympathetic denervation, Uncontrolled hypertension, Chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Denervation

Arm Type

Experimental

Arm Description

Participation receiving renal sympathetic denervation

Intervention Type

Device

Intervention Name(s)

Renal Sympathetic Denervation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days

Description

Change in eGFR from baseline to 7 days and 1 month as measure of safety in terms of kidney function

Time Frame

at baseline, 7days and 30 days

Secondary Outcome Measure Information:

Title

Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months

Description

Change in kidney function from baseline to 7 days, 1, 3, and 6 months

Time Frame

at baseline, 7 days, 1, 3, and 6 months

Title

Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.

Description

Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.

Time Frame

at baseline, 1, 3, and 6 months

Title

Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months

Description

Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months

Time Frame

at baseline and 6 months

Title

Change in office blood pressure from baseline to 1,3, and 6 months

Description

Change in office BP from baseline to 1,3, and 6 months for efficacy

Time Frame

at baseline, 1, 3, and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Indranil Dasgupta, DM

Organizational Affiliation

Heart of England NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Heart of England NHS Foundation Trust

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B9 5SS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

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