PROFID EHRA
Research type
Research Study
Full title
Prevention of sudden cardiac death after myocardial Infarction by Defibrillator implantation (PROFID EHRA)
IRAS ID
331024
Contact name
Nikolaos Dagres
Contact email
Sponsor organisation
Charité - Universitätsmedizin Berlin
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
Patients with heart attack (myocardial infarction) are at increased risk of death because of abnormal heart beats. Life threatening abnormal heart beats occur when the heart beats too fast (ventricular tachycardia / ventricular fibrillation) and can result in sudden cardiac death.
Patients with heart attack can also have a reduced pump function of the heart (heart failure). This function is determined by the amount of blood that the heart pumps, which is measured using a term called left ventricular ejection fraction.
Under current guidelines, patients with heart attack and heart failure with a left ventricular ejection fraction less than 35% can be offered an implantable cardioverter defibrillator (ICD). An ICD is a device that sits under the skin near the collar bone connected to the heart by wires and automatically delivers an electric shock in the event of life threatening heart beat.
However, the current guidance for the ICD use was based on studies that were conducted about 20 year ago – before advances in the treatment of heart failure. Moreover, nowadays the risk of dying from a heart beat abnormality in people with heart attack and heart failure is much lower than 20 years ago. Therefore, due to improved medicines, ICDs may not be necessary.
The aim of this trial is to test whether patients with heart attack and severe heart failure who are receiving optimal medical therapy and carry an ICD have the same risk of dying as patients with this condition but without an ICD.
We will test this in a scientifically robust study called randomized clinical trial. Patients who consent to participate will be given a 50:50 chance of receiving an ICD. They will be followed-up for about 2.5 years.
The trial is called PROFID EHRA and is being run in many countries in Europe.REC name
London - Bromley Research Ethics Committee
REC reference
24/LO/0742
Date of REC Opinion
7 Mar 2025
REC opinion
Further Information Favourable Opinion