Science
First patients enter a groundbreaking clinical trial to improve how implantable cardioverter defibrillators are used
The first patient has undergone surgery in a landmark clinical trial we are funding which aims to improve treatments for heart failure to help prevent sudden cardiac death.
Heart patient Phil O’Donoghue is taking part in the BRITISH study, which is funded by £1.8m from us.
The trial aims to find out which patients with heart failure may benefit from having an implantable cardioverter defibrillator (ICD) fitted, to shock their heart if it goes into cardiac arrest.
The trial will recruit 2,500 people at 35 hospital sites across the UK over the next three years. You can see which hospital sites are currently recruiting patients and where the trial is due to open on the BRITISH website.
A world-first trial
Heart failure affects over 900,000 people in the UK, with around 200,000 new cases diagnosed each year, and an estimated cost of £2bn to the NHS.
ICDs are small devices that are routinely fitted in the chests of patients with heart failure. They can stop abnormal rhythms and treat cardiac arrest by delivering an electric shock to the heart.
The study is being led by consultant cardiologists Dr Andrew Flett and Professor Nick Curzen from University Hospital Southampton (UHS) and is co-ordinated by the NIHR Southampton Clinical Trials Unit.
“The current guidelines look at how well the heart is pumping to decide which patients should get a defibrillator,” says Dr Andrew Flett, chief Investigator of the BRITISH trial.
“But for many patients who go through the procedure of having a defibrillator fitted, they will never actually see the device triggered and may not need it. We therefore want to find a better way to assess which patients will truly benefit from one of these devices.
“There is evidence that scar tissue in the heart muscle may be the cause of dangerous heart rhythms for patients with NICM.
"This will be the first ever trial to look at whether the presence of scar tissue can predict who should be fitted with an ICD.”
An MRI scan is used to detect the presence of scar tissue in the heart and those patients are invited into the trial.
“Participants are randomly allocated to one of two trial arms,” says Professor Nick Curzen, co-investigator on the trial. “Half will be fitted with an implantable defibrillator.
"The others will be fitted with an implantable loop recorder (ILR), a device which monitors heart activity so that the team can review any abnormal rhythms, but which does not shock the heart.”
First patient
Phil O’Donoghue, 53, suffers from non-ischemic cardiomyopathy (NICM). This is a common type of heart failure which can lead to abnormal heart rhythms, and sudden cardiac arrests are a possible cause of death in these patients.
He says the diagnosis of heart failure has had a big effect on his day-to-day life. “I can’t do the things I want to do if it means exerting myself. I had to change what I did at physically at work.”
Phil is in the defibrillator arm and this week was the first patient enrolled in the trial to have the device fitted at University Hospital Southampton.
“Having the defibrillator doesn’t bother me, it’s just one of those things. If it goes off, it goes off. And if it doesn’t, then great. But if the trial can show one way or another whether they should be used, and move treatments forward, then it’s obviously a benefit.”
Finding the treatments of the future
Professor Sir Nilesh Samani, our Medical Director, said: “ICDs are crucial devices to treat sudden cardiac arrest and save lives.
"But it is important that we continue to establish exactly which patients need them, so that people who are unlikely to benefit do not have to undergo invasive procedures unnecessarily.
“The BRITISH trial will test whether the presence of scar tissue in the heart predicts who will benefit most from having an ICD.
"Funding the trial demonstrates the BHF's continuing commitment to improving the treatment of patients with heart disease, by gathering the best evidence through high-quality research.”
The trial is currently open to patients at five hospitals in Southampton, Portsmouth, Aberdeen, East Kent, and Barts in London, with a further 30 sites to open in the coming months.
Dr Flett added, “The ultimate goal of any research is to improve treatment for our patients. The BRITISH trial will inform UK and international guidelines for the treatment of heart failure.
"Depending on the outcome of the study, it could identify a group of patients who we know will benefit from ICDs and reduce unnecessary procedures for patients who don’t need them ensuring cost effective use of our health service in the future.”