The first clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction survivors with heart failure has enrolled its first patient. The PROFID EHRA trial is part of the EU-funded PROFID project, which aims to personalize the prevention of sudden cardiac death after myocardial infarction and involves a consortium of 21 multidisciplinary partners including the European Society of Cardiology (ESC).
Sudden cardiac death is a major public health problem responsible for approximately one in five fatalities in Europe. Most sudden cardiac deaths occur in myocardial infarction survivors. To prevent these deaths, patients whose heart pumps less well than it should following a heart attack currently 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 life-saving ICD shocks.
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."
Dr. Nikolaos Dagres, chief investigator of the trial
The study will 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 in heart attack survivors with heart failure and a reduced pump function.
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 trial will recruit some 3,595 patients from 180 hospitals in 13 countries - namely 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 are being randomly allocated to 1) optimal medical therapy alone or 2) 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 Jose L. Merino, EHRA president and national coordinator of the PROFID EHRA trial in Spain, said: "The PROFID EHRA trial is set to redefine the use of ICDs in myocardial infarction survivors, and is therefore a very important scientific study for the European Heart Rhythm Association (EHRA) and for clinical practice globally."