The PROFID team developed and validated a Clinical Prediction Model for predicting the SCD risk of individuals with previous MI with the aim to assess the expected benefit of ICD implantation for SCD prevention across the whole range of LVEF (WP1). The primary finding of this analysis was that consideration of a large number and variety of clinical parameters collected during routine care showed a poor predictive performance for the risk of SCD in patients with previous MI or ischemic cardiomyopathy with reduced LVEF <50%. CMR imaging did also not improve risk prediction for SCD after myocardial infarction in the largest pooled patient cohort collected to date. Based on these results, the trial design was adapted accordingly. The PROFID EHRA trial investigates whether in post-MI patients with symptomatic heart failure and reduced LVEF ≤35% who receive OMT, OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality. More than 600 hospitals in 12 countries in Europe were classified as potentially eligible for study participation and key opinion leader-physicians in these countries were nominated.
Since 2023, the main focus was on the start and implementation of the PROFID EHRA clinical trial (WP2/WP3), including ethics committee submissions; identification, contracting and preparation of study sites as well as activating study sites for patient enrolment, which started in November 2023. Until June 2024, ethics committee approvals have been obtained in 7 European countries and 24 study sites are open for recruitment. The predictive role of novel SCD risk markers will be prospectively assessed by AI analysis of the 12-lead electrocardiogram and by use of AI techniques in two optional PROFID EHRA sub studies, focusing on genomics and cardiac MRI.
The clinical trial has been renamed from “PROFID” to "PROFID EHRA" in 2023 to emphasise the close collaboration with and the strong support of the European Heart Rhythm Association (EHRA). Furthermore, since 1 January 2024, Charité - Universitätsmedizin Berlin has taken over the role of project coordinator and sponsor of the clinical study.
As part of the health economic analysis (WP5), the national health technology assessment organizations and their respective manuals for the countries participating in the PROFID EHRA trial have been compared. A budget impact analysis, which aims to assess whether the introduction of the “PROFID approach” leads to cost changes for the healthcare system in each participating country, is ongoing. The health economics protocol for the PROFID EHRA trial was finalized.
Ethical guidance on consent and related issues (WP6) is of major importance. A “Report on ethical and legal aspects of personal medicine, AI and machine learning” was written, which presents results regarding trust in health data research. A guidance document addressing novel ethical issues and a manuscript on non-inferiority trials' ethics was prepared as well. For setting up the planned PROFID EHRA Incidental Findings Committee, an associated charter was prepared. In addition, an interview study on patient views regarding AI's potential impact on decision-making and patient care was conducted.
The work performed within WP7 has been pivotal in further advancing the international recognition of the PROFID project and especially the PROFID EHRA trial, through intense and various strategic promotion and dissemination efforts. Outstanding visibility was achieved at all EHRA and ESC Congresses held since the start of the project, as well as numerous further national and international congresses and events.
The results of WP1 are reported in a manuscript that was accepted for publication in a leading Cardiology journal.
