The first clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction (MI) survivors with heart failure is enrolling patients.

The PROFID EHRA trial aims to personalise the prevention of sudden cardiac death after MI and involves a consortium of 21 multidisciplinary partners, including the European Society of Cardiology (ESC).

Most sudden cardiac deaths occur in MI survivors. To prevent these deaths, many patients receive an implantable cardioverter defibrillator (ICD). However, modern drug treatments have been shown to lower the risk of sudden death in these patients, thereby reducing the need for ICD administration.

Dr Nikolaos Dagres, chief investigator of the trial, said: “The PROFID EHRA is re-evaluating the role of ICD implantation in post-MI patients in the context of contemporary medical treatment and will provide vital new information to optimally guide therapy and address this serious health issue.”

The study will test whether in post-MI 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 in heart attack survivors with heart failure and a reduced pump function.

Prof Gerhard Hindricks, chief investigator of the trial, said this is a ground-breaking study that could change the prevention of sudden cardiac death in clinical practice. 

He said that 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 that may lead to complications or unintended shocks from the device.”

The trial is recruiting 3,595 patients from 180 hospitals in 13 countries. Participants are being randomly allocated to optimal medical therapy alone or optimal medical therapy plus ICD implantation. They 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 results are expected in 2027.