The first clinical trial to challenge routine implantation of a defibrillator in myocardial infarction survivors with heart failure has enrolled its first patients. 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 accounting for approximately one in five deaths in Europe. Most sudden cardiac deaths occur in survivors of myocardial infarction. To prevent these deaths, people whose hearts pump less than they should after a heart attack should currently receive an implantable cardioverter defibrillator (ICD). However, modern drug treatments have been shown to reduce the risk of sudden death in these patients, thereby reducing the need for life-saving ICD shocks.
The PROFID EHRA trial is set to impact clinical practice around the world by closing a huge evidence gap that has existed for the past 20 years. “The trial is reevaluating the role of ICD implantation in post-myocardial infarction patients in the context of contemporary medical treatment and will provide important new information to optimally guide therapy and address this serious health problem.”
Dr. Nikolaos Dagres, chief investigator of the trial
The study will examine whether drug treatment is non-inferior to drug treatment alone in post-myocardial infarction patients with symptomatic heart failure and reduced left ventricular ejection fraction (35% or less) and an ICD to prevent sudden death from heart failure in heart attack survivors. and a reduced pump function.
Professor Gerhard Hendricks, principal investigator of the trial, said: “The PROFIT EHRA is a breakthrough study that could change the prevention of sudden cardiac death in clinical practice. Currently, many patients who receive ICDs never need them, while some who do miss out on the benefits. This trial is novel, will provide randomized evidence on which patients should receive a defibrillator and which patients may be spared an unnecessary procedure that typically requires an overnight hospital stay and may result in complications or unintended shock from the device.”
The trial will recruit approximately 3,595 patients from 180 hospitals in 13 countries – Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands and the United Kingdom. The first patient was enrolled from the Sageberger Clinic, a heart center in Germany.
Participants were randomly assigned to 1) optimal medical therapy alone or 2) optimal medical therapy plus ICD implantation. Participants will be followed for approximately 2.5 years for the primary outcome of all-cause mortality. The investigators will also examine the effect of the two treatment strategies on death from cardiovascular causes, sudden cardiac death, hospitalization for cardiovascular causes, length of hospital stay, quality of life and cost-effectiveness. The study will last about 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 Europeans. Heart Rhythm Association (EHRA) and for clinical practice worldwide.