In order to reach the final goal, the following main phases have been designed for the PROFID project:
Clinical prediction model development
In the first phase, a variety of data from different settings will be included in order to develop a clinical prediction model for the individual risk of sudden cardiac death. This model will be based on a collection of existing highly phenotyped data with the largest number of post- myocardial infarction patients ever in this regard (~1,000,000 patients of both sexes). The databases represent a wide variety of data sources such as national registries, institutional research databases, electronic health records and claims databases.
In the second phase, two parallel randomised clinical trials will validate the utility of use of the clinical prediction model for the decision making on implantable cardioverter defibrillator implantation, while health economic analyses will assess its economic impact on health care systems. Both studies are prospective, parallel-group, randomised, open-label, multi-centre, blinded outcome assessment (PROBE), event-driven trials.
- Trial 1: PROFID-Reduced Non-inferiority trial in reduced LVEF and low sudden cardiac death risk
Non-inferiority controlled clinical trial without investigational product (Proof of Strategy Trial). This trial will be conducted on about 2,500 patients with a LVEF≤35% and a low risk for sudden cardiac death as predicted by the clinical prediction model that would receive an ICD according to current guidelines with randomised comparison of the ICD versus just optimal medical treatment without ICD.
- Trial 2: PROFID-Preserved Superiority trial in preserved or moderately reduced LVEF and high sudden cardiac death risk
Superiority controlled clinical trial without investigational product (Proof of Strategy Trial). This trial (“PROFID-Preserved”) will be conducted on more than 1,400 patients with a LVEF>35% and a high risk for sudden cardiac death as predicted by the clinical prediction model that would not receive an ICD according to current guidelines with randomised comparison of the ICD versus just optimal medical treatment without ICD.
Online web-based tool
A software tool for clinical use of the risk score will be implemented and hosted at the website of the European Society of Cardiology. The unique composition of the PROFID consortium with participation of key opinion leaders, patient organisations, large hospital chains, payers, policy makers and state authorities across Europe, will ensure implementation into routine clinical practice. > Lay Summary
For more information about the methodology of this project, please click here.