First patients join clinical trial to help reduce sudden cardiac deaths

The first patient has had surgery in a landmark clinical trial to reduce deaths from sudden cardiac arrests.

Heart patient Phil O’Donoghue is taking part in the BRITISH study at University Hospital Southampton (UHS).

The trial is funded by £1.8m from the British Heart Foundation. It aims to work out which patients could benefit from having an implantable cardioverter defibrillator fitted under the skin in their chest.

Consultant cardiologists Dr Andrew Flett and Professor Nick Curzen are leading the trial. It is co-ordinated by the NIHR Southampton Clinical Trials Unit (SCTU).

Over 2,500 patients will be recruited across the UK in the next three years.

First patient

Phil O’Donoghue, 53, suffers from non-ischemic cardiomyopathy (NICM). It is a common type of heart failure which can lead to abnormal heart rhythms. Sudden cardiac arrests are a major cause of death in patients with the condition.

Phil, who is from Chandler’s Ford in Hampshire, went to A&E during the first Covid-19 lockdown in May 2020 after suffering palpitations and feeling unable to breathe. The diagnosis 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,” he explains. “I had to change what I did at work. I do a lot of fishing for relaxation but pushing all my gear on the cart means I get very breathless. I used to ride motorbikes and do track days but pushing and pulling the bike around is hard work.”

Phil was on medication for two and a half years until he suffered further episodes earlier this year.

“I was rushed into hospital and tests showed my heart’s ejection rate was down to 24%. This meant my heart was not pumping blood around my body properly. I was told there was a trial about to start and that I fitted what they were looking for.”

“I’ve always been involved in research,” says Phil. “My mum was a nurse, and when my daughter was born, doctors followed her for 16 years looking at things like bone density. When I spoke to Dr Flett, it made perfect sense to go ahead and do the trial.”

World-first trial

Heart failure affects over 900,000 people in the UK. There are around 200,000 new cases each year, which costs the NHS an estimated £2bn.

Implantable cardioverter defibrillators (ICDs) are small devices fitted in a patient’s chest. They can stop abnormal rhythms and treat cardiac arrest by delivering an electric shock to the heart.

Current guidelines look at how well the heart is pumping to decide which patients should get an implant, but this may not be the best method. Many patients who have an ICD fitted will never benefit from it.

“As with any surgical procedure, there is a risk of complications from having an ICD fitted,” explained Dr Andrew Flett, Chief Investigator of the BRITISH trial.

“We therefore want to find a better way to assess which patients will truly benefit from one of these devices before it is fitted.

“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 scar tissue can predict who should be fitted with an ICD.”

Trialling two treatments

Researchers in 35 UK hospitals will recruit over 2,500 NCIM patients. They can take part if an MRI scan has detected evidence of scarring in the heart.

“Participants are randomly allocated to one of two trial arms,” says Professor Nick Curzen, co-investigator on the trial.

“One half will be fitted with an ICD and the other half will be fitted with an implantable loop recorder (ILR). The ILR device monitors heart activity so that the team can review abnormal rhythms but does not shock the heart.”

Phil is in the defibrillator arm. This week, he became the first patient enrolled in the trial to have the device fitted at UHS.

Lifesaving research

Recruitment of the first patients to the BRITISH trial comes during the British Heart Foundation’s ‘This is Science’ campaign. It aims to raise awareness of the lifesaving research the charity funds.

Professor Sir Nilesh Samani, Medical Director of the British Heart Foundation, 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. Another 30 sites will open in the coming months.