With the initiation of the first clinical study sites in Bad Segeberg and Rothenburg, Germany, and the enrolment of the first patients, the PROFID EHRA trial has finally started. From now on the 30-month recruitment period is underway.
The PROFID EHRA trial (NCT05665608) is set to answer the question if routine implantation of an implantable cardioverter defibrillator (ICD) in myocardial infarction survivors with heart failure is still an adequate therapy for prevention of sudden cardiac death. It is the first randomised adequately powered assessment of the potential benefit of ICD therapy in myocardial infarction survivors with reduced LVEF under contemporary optimal medical therapy.
The trial plans to include 3,595 patients from 180 hospitals in 13 countries. Participants will be randomly assigned to receive either optimal medical therapy alone or combined with ICD implantation. Over about 2.5 years, the study will assess outcomes such as all-cause death, cardiovascular deaths, sudden cardiac death, hospital readmissions, length of hospital stay, quality of life, and cost-effectiveness. The trial is expected to last around 49 months, and results are anticipated in early 2027.
This PROFID EHRA trial is a significant step forward in medical research, challenging traditional practices to provide urgently needed contemporary data on sudden death prevention by defibrillator implantation after myocardial infarction and is expected to profoundly influence clinical practice.
A press release distributed by the European Society of Cardiology marked the event