The first clinical trial to challenge the routine use of implantable cardioverter defibrillators (ICDs) in myocardial infarction survivors with heart failure has enrolled its first patient.
With modern drug treatments demonstrating the ability to lower the risk of sudden death in these patients, there is potentially less of a need for life-saving ICD shocks.
The PROFID EHRA trial will therefore test whether in post-myocardial infarction patients with symptomatic heart failure and reduced left ventricular ejection fraction (35% or less) drug treatment alone is not inferior to drug treatment plus an ICD for preventing sudden death.
Dr Nikolaos Dagres, chief investigator of the trial, said: ‘The PROFID EHRA trial is set to influence clinical practice around the world by closing a huge evidence gap that has existed for the past 20 years.
‘The trial is re-evaluating the role of ICD implantation in post-myocardial infarction patients in the context of contemporary medical treatment and will provide vital new information to optimally guide therapy and address this serious health issue.’
Over the next 30 months, the trial will recruit some 3,595 patients from 180 hospitals in 13 countries: Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands and the UK.
The first patient was enrolled from the Heart Centre Segeberger Kliniken in Germany.
Participants will be randomly allocated to either optimal medical therapy alone or optimal medical therapy plus ICD implantation. Participants will be followed up for around 2.5 years for the primary outcome of all-cause death.
The investigators will also examine the impact of the two treatment strategies on death from cardiovascular causes, sudden cardiac death, hospital readmissions for cardiovascular causes, length of stay in hospital, quality of life and cost effectiveness.
The study is due to last for approximately 49 months, with results expected in early 2027.
Professor Gerhard Hindricks, chief investigator of the trial, said: ‘PROFID EHRA is a ground-breaking study that could change the prevention of sudden cardiac death in clinical practice.
‘Currently, many patients who receive an ICD never need one, while some who could benefit miss out.
‘This trial will provide novel, randomised evidence on which patients should receive a defibrillator, and which patients can be spared an unnecessary procedure, which typically requires an overnight stay in hospital and may lead to complications or unintended shocks from the device.’
The PROFID EHRA trial is part of the PROFID project, which aims to personalise the prevention of sudden cardiac death after myocardial infarction.
The project involves a consortium of 21 multidisciplinary partners, including the European Society of Cardiology, and has received funding from the European Union’s Horizon 2020 research and innovation programme.