New trial sets out to challenge routine defibrillator implantation
A clinical trial to personalise the prevention of sudden death after a myocardial infarction, or heart attack, has just enrolled its first four patients. Part of the EU-funded PROFID project, it is the first trial of its kind to challenge the routine implantation of defibrillators in heart attack survivors with heart failure. The trial is being held in collaboration with the European Heart Rhythm Association (EHRA), a branch of PROFID project partner European Society of Cardiology (ESC), France. Responsible for about 20 % of fatalities in Europe, sudden cardiac death mostly occurs in people who have previously had a myocardial infarction. To prevent these deaths, doctors use implantable cardioverter defibrillators (ICDs). However, given the effectiveness of modern drug treatments in lowering the risk of sudden death in heart attack survivors, is routine ICD use really necessary? This is what the research team aims to find out. EHRA member and trial co-lead Dr Nikolaos Dagres of Charite Campus Virchow Clinic, Germany, states in a ‘EurekAlert!’ news release: “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.”
Two treatment strategies
The trial will test whether drug treatment alone could prevent sudden death just as effectively as drug treatment plus an ICD for post-heart attack patients with symptomatic heart failure and reduced pump function. Participants will be followed up for about 2.5 years. The researchers will also investigate the impact of the two treatment approaches on death from cardiovascular causes, sudden cardiac death, hospital readmissions for cardiovascular causes, length of hospital stay, quality of life and cost effectiveness. The plan is to recruit 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. So far, the PROFID EHRA trial has enrolled four patients from three participating clinical sites: three patients from two hospitals in Germany, and one patient from a hospital in Czechia. ESC and EHRA member and trial co-lead Prof. Gerhard Hindricks of Charite University Hospital, Germany, remarks: “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 study will last around 49 months, with results expected in early 2027. The PROFID (Implementation of personalised risk prediction and prevention of sudden cardiac death after myocardial infarction) project ends in December 2024. For more information, please see: PROFID project website
Keywords
PROFID, myocardial infarction, heart attack, defibrillator, implantable cardioverter defibrillator, sudden cardiac death, heart failure