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Southampton Clinical Trials UnitNews

New £1.8m clinical trial to help reduce sudden cardiac deaths using implantable defibrillators

Published: 19 August 2022
Cardiac arrest and defibrillator

A team of Southampton researchers have been awarded £1.8m from the British Heart Foundation to run a new clinical trial aimed at improving treatment for people diagnosed with heart failure.

The BRITISH trial is led by consultant cardiologists Dr Andrew Flett and Professor Nick Curzen from University Hospital Southampton (UHS) and Southampton University, and will be co-ordinated by the Southampton Clinical Trials Unit and the Coronary Research Group at UHS. The aim of the study is to work out which patients may benefit from having an implantable cardioverter defibrillator (ICD) fitted under the skin in their chest.

The trial will see researchers in 35 UK hospitals recruit over 2,500 patients with non-ischaemic cardiomyopathy (NICM) and evidence of scarring of the heart muscle who will then be randomised to have an ICD or not.

Non-ischaemic cardiomyopathy (NICM) is a common cause of heart failure accounting for around a third of cases. 'Non-ischaemic' refers to the fact that the weakness of the heart muscle that characterises the condition is not primarily due to the blodd flow down the coronary arteries. Some patients with NICM can be at the risk of sudden cardiac death due to dangerous, very fast heartbeats which can cause cardiac arrest.

Implantable cardioverter defibrillators (ICDs) can treat cardiac arrest and stop fast, abnormal heart rhythms by delivering an electric shock to the patient’s heart. The current guidelines look at how well the heart is pumping to decide which patients should get an implant.


Dr Andrew Flett
Dr Andrew Flett

“These guidelines use an arbitrary cut-off of pump function,” says Dr Flett. “But a previous large trial has shown that most patients with NICM and an implantable defibrillator will never benefit from it. This also needs to be balanced against the risk of complications from an ICD, and so we want to find a better way to assess which patients will truly benefit from one of these devices before it is fitted.”

“Evidence suggests that it is actually scar tissue within the heart that causes abnormal heart rhythms, and we believe this could be a better measure of the risk of sudden cardiac death for a patient and so will identify patients most likely to need an ICD.”

The BRITISH trial will recruit NICM patients where an MRI scan has detected the presence of scar tissue in the heart. They will then be randomly allocated to one of two trial arms, with half being fitted with an implantable defibrillator.

“We will be able to look at patient data to compare outcomes after three and five years in the two groups to find out whether these patients need an ICD or not,” says Senior Trial Manager Zina Eminton from Southampton Clinical Trials Unit. “If we find there is a difference in mortality, it will mean that all patients with NICM should have a cardiac MRI scan to determine whether they have scar tissue on the heart, and those that do would be offered an ICD.”

The trial will also involve a registry of patients who do not have scar tissue and are therefore treated according to current clinical guidelines.

Dr Flett concludes, “If the BRITISH trial is positive, it could stimulate a change in international and UK guidelines for the treatment of NICM heart failure and implantable devices. We hope this would improve clinical outcomes for these patients in the future and help reduce costs for our health service by ensuring only those who will benefit from ICDs have them fitted.”


Notes for editors

The BRITISH trial - Using cardiovascular magnetic resonance identified scar as the Benchmark Risk Indication Tool for Implantable cardioverter defibrillators in patients with Non-Ischaemic Cardiomyopathy and Severe systolic Heart failure

The Southampton Clinical Trials Unit (SCTU) is a National institute for Health and Care Research (NIHR) supported and Cancer Research UK (CRUK) core-funded CTU with expertise in the design, conduct and analysis of interventional, multi-centre clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. For more information, visit the SCTU website.

University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2020/21. UHS provides hospital services for 1.9 million people living in southern Hampshire and specialist services – including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children’s services – to more than 3.7 million people in central southern England and the Channel Islands. UHS is consistently one of the UK's highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. In partnership with the University of Southampton, UHS has £27 million of NIHR infrastructure dedicated to bringing the latest treatments to patients. Visit the UHSFT website.

The University of Southampton (UoS) drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s challenges. We are among the top 100 institutions globally (QS World University Rankings 2023). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 22,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 200,000 alumni.


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