Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

NCT ID: NCT02863510

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-07-31

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.

Conditions

Hypertension; Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Denervation

Participation receiving renal sympathetic denervation

Group Type: EXPERIMENTAL

Renal Sympathetic Denervation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart of England NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Indranil Dasgupta, DM

Role: PRINCIPAL_INVESTIGATOR

Heart of England NHS Foundation Trust

Locations

Heart of England NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

2012138RN

Identifier Type: -

Identifier Source: org_study_id