The long-term safety and effect of renal denervation
Research type
Research Study
Full title
The long-term safety and effect of renal denervation for resistant hypertension
IRAS ID
141953
Contact name
Justin Davies
Contact email
Sponsor organisation
Imperial College London
Research summary
Renal denervation is emerging as a succesful technique in the treatment of high blood pressure particularly for those people who’s disease is resistant to drug therapy. It involves insertion of an catheter through the femoral artery and into the renal artery where it delivers a controlled radiofrequency ablation to the renal artery wall.
The purpose of this ablation is to interupt the sympathetic nervous system which is inappropriately activated in hypertension. Its beneficial effects on BP reduction has been borne out in a recently published randomised clinical trial which demonstrated a reduction in blood pressure in patients who underwent denervation compared to those managed with medication alone and it is now being used worldwide to manage hypertensive patients.
The safety of this procedure has been demonstrated in the peri-operative setting and short term particularly regarding anatomical changes and kidney function. However, its effects have not been demonstrated with invasive imaging or physiological testing in the long term. Therefore, we recognise that a repeat assessment 6 months after denervation using invasive measures (to perform detailed assessments of the effects on aortic and left ventricular pressure, flow and artery stiffness) and imaging techniques (to assess any potential negative anatomical effects) would be of great benefit in stratifying this technique, which is likely to become widespread in the very near future.
We therefore plan to perform denervation in 20 patients and obtain detailed information on kidney, aortic and left ventricular blood pressure and flow, as well as a sophisticated invasive assessment of the wall of the kidney arteries using optical coherence tomography (OCT). We will then reassess these parameters after 6 months in the same patients to ensure artery patency, preservation of pressure, flow and energy transfer, a healthy structure of the wall of the kidney artery and document the effects of denervation on vascular stiffness.
REC name
London - Bromley Research Ethics Committee
REC reference
14/LO/0026
Date of REC Opinion
28 Jan 2014
REC opinion
Further Information Favourable Opinion