Southampton study hopes to reduce heart failure deaths
Researchers have been given almost ÂŁ2 million from the British Heart Foundation
A team of researchers in Southampton are hoping to save lives by working out which patients should have a heart-starting device fitted.
They have been awarded ÂŁ1.8m 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 and will be co-ordinated by the NIHR Southampton Clinical Trials Unit.
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 funding from the British Heart Foundation will see researchers in 35 UK hospitals recruit over 2,500 patients with non-ischaemic cardiomyopathy (NICM) and evidence of scarring within the heart who will then be randomised to have a defibrillator 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 there is no narrowing of the coronary arteries (the most common cause of heart failure). Some patients with NICM can be at higher 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 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 Flett said:
“These guidelines use an arbitrary cut-off of pump function.
“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.
The trial will also involve a registry of patients who do not have scar tissue and are therefore treated according to current guidelines.
Dr Flett concludes, “If the BRITISH trial is successful, 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.”