A trial of a new procedure to help people with high blood pressure jointly conducted by an East London health trust and local university has found that the pressure of hypertension patients was significantly reduced and continued to remain low six months after the operation.
Barts Health NHS Trust and Queen Mary, University of London, lead the international trial that used ultrasound energy to disrupt nerve signals between the kidneys and the brain in order to control blood pressure.
The hour-long ‘renal denervation’ operation has been proven to lower blood pressure. This means that patients, such as those that do not respond to antihypertensive drugs, can control their blood pressure, which reduces the risk of cardiovascular disease that can lead to stroke or heart attack.
Dr. David Kandzari, Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, said on an earlier stage of the trial: “A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches. This trial will add yet another critical piece to the RDN evidence basis and is designed to build on the success of our pilot study, which showed a benefit for RDN in an on-med patient population.”
The trial took place at St Bartholomew’s Hospital, London, and was supported by the NIHR (National Institute for Health Research) biomedical research centre. Patients from the United States, France, Germany, Netherlands, Belgium, and the UK took part in randomised testing, with half of the patients being offered renal denervation and half receiving a placebo ‘sham’ operation.
The results of the trial, published on 17 March, showed that patients who did not take antihypertensive drugs demonstrated significant blood pressure lowering effects two months after the operation.
The study also found that of those who restarted their medication after the procedure, 58% of patients who had had renal denervation maintained the lowering effects after six months, compared to just 42% who had been in the ‘sham’. The majority of patients in the trial still needed medication to control their blood pressure after the trial, however the ‘sham’ group demonstrated half the number of medication free patients than the group that underwent renal denervation.
The report on the findings of the trial has been presented at the American College of Cardiology Conference in New Orleans, USA, and the next stage of the trial will be to examine findings over a longer test period.
Professor Melvin Lobo, UK Principal Investigator from Barts Health NHS Trust and Queen Mary, University of London, said: “These results point towards an exciting future for this new technology. If long term safety and efficacy is proven in larger trials which are currently under way, we hope that renal denervation therapy could soon be offered as an alternative to many lifelong medications for hypertension.”