BACKGROUND: Randomised clinical trials from over 20 years ago demonstrated that an implantable cardioverter defibrillator (ICD) improved survival for patients with severely reduced left ventricular ejection fraction (LVEF) after myocardial infarction (MI) compared with optimal medical therapy (OMT) alone. Since then advances in therapy have led to the reduction in the incidence of sudden cardiac death (SCD) in this population, whilst complication rates from ICD implantation are still substantial. OBJECTIVES: To determine whether OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality. DESIGN: The PROFID EHRA trial is an investigator-driven, prospective, parallel-group, randomised, open-label, blinded outcome assessment (PROBE), multi-centre, non-inferiority trial without dedicated investigational medical device (Proof of Strategy Trial) with two groups with 1:1 randomisation. PROFID-EHRA will recruit approximately 3,595 patients with documented history of MI at least three months prior, LVEF ≤35%, on OMT for at least 3 months, and with New York Heart Association class II or III, who will be randomised to OMT or OMT plus ICD, to collect 374 first primary outcome events within a median observation period of around 28 months from about 180 clinical sites in an estimated 13 countries. The primary outcome is time from randomisation to the occurrence of all-cause death. Secondary outcomes include time from randomisation to death from cardiovascular causes, to SCD, to first hospital readmission for cardiovascular causes after date of randomisation, the average length of hospital stay during follow-up, and quality of life trajectories. SUMMARY: The PROFID-EHRA trial will provide contemporary evidence for the use of ICD implantation in patients with MI and severely reduced LVEF. CLINICAL: Trials.gov NCT05665608.

Arrhythmia and Robotic Electrophysiology Unit La Paz University Hospital IDIPaz Madrid Spain; Hospital Viamed Santa Elena Madrid Spain

Clinical Epidemiology and Biostatistics The AMC Amsterdam The Netherlands

Department of Cardiology Aarhus University Hospital and Department of Clinical Medicine Aarhus University Aarhus Denmark

Department of Cardiology Angiology and Intensive Care Medicine Charité Campus Mitte German Heart Center of the Charité University Medicine Berlin Berlin Germany

Department of Cardiology AZORG Aalst Belgium

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center Maastricht Netherlands

Department of Cardiology Rambam Health Care Campus Haifa Israel

Department of Cardiology University Heart and Vascular Center Hamburg Germany

Department of Clinical Electrophysiology Ordensklinikum Linz Elisabethinen Linz Austria

Department of electrophysiology Hdz Nrw Bad Oeynhausen Gemany

Department of Internal Medicine 1 Cardiology Olomouc University Hospital Moravia Czech Republic

Division of Cardiology Department of Medicine Karolinska Institutet Stockholm Sweden; Heart Vascular and Neuro Theme Karolinska University Hospital Stockholm Sweden

Division of Cardiology McGill University Health Centre McGill University Montreal Canada

Heart and Vascular Centre Semmelweis University Budapest Hungary

Heart Center Leipzig at the University of Leipzig Leipzig Germany

Heart Rhythm Management Centre Postgraduate Program in Cardiac Electrophysiology and Pacing Universitair Ziekenhuis Brussel Vrije Universiteit Brussel European Reference Networks Guard Heart Brussels Belgium; Cardiology Heart Rhythm Management Department Clinique Pasteur Toulouse France

Leeds Institute for Cardiovascular and Metabolic Medicine University of Leeds UK; Leeds Institute of Data Analytics University of Leeds UK; Department of Cardiology Leeds Teaching Hospitals NHS Trust Leeds UK

University of Rochester Medical Center Clinical Cardiovascular Research Center Rochester NY USA

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ClinicalTrials.gov
NCT05665608