A huge milestone has been reached for the PROFID EHRA trial (NCT05665608), which 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. After an extensive period of trial set up and Ethics Committee submission the first study sites in Germany and Czech Republic have been opened for recruitment and the first patients have been enrolled at the Heart Center Bad Segeberg and ANregiomed Klinik Rothenburg in Germany. The PROFID EHRA trial will enrol approximately 3,600 patients from 180 clinical sites in 13 countries. It will be 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.
Martin, you are the principal investigator at the first study site initiated in the PROFID EHRA trial and you have also enrolled the first patient. Why is the conduction of this trial necessary for our patients?
Martin Borlich: “The PROFID EHRA trial´s significance lies in its evaluation of defibrillator use in post-MI patients, considering improved heart failure therapy, ultimately enhancing patient care by providing up-to-date evidence.”
Martin, for you personally, why is it important to support and participate in the PROFID EHRA trial?
Martin Borlich: “I appreciate the collaboration with Prof. Hindricks, PD Dagres and Prof. Sommer. As with the RESET-CRT study, the research question has the potential to impact guidelines and provides essential data on the role of prophylactic ICD implantation more than 20 years after the MADIT II trial.”
Philipp, you are the National Coordinator of Germany in the PROFID EHRA trial. What does this role exactly mean and what are your current tasks?
Philipp Sommer: “I try to coordinate the regional aspects of this study like identifying suitable sites for study participation, but also to be available for the local Principal Investigator of the participating centers for their practical questions like inclusion/exclusion criteria and other very practical aspects of the study.”
Martin, what have you observed in the clinical situation in the treatment of post-MI patients over the last few years?
Martin Borlich: “Advances in heart failure therapy led to a decreased risk of sudden cardiac death impacting the consideration of prophylactic ICD implantation. This evolving landscape emphasized the need for studies like PROFID EHRA to reassess the role of ICDs in contemporary patient care.”
Martin, patients may have doubts about taking part in the trial, how can this be addressed?
Martin Borlich: “Up to now, we have recommended an ICD for these patients solely based on their LVEF. Many patients are uncertain if they really need one or hold hope that their EF may improve over time. Taking into consideration the improved possibilities of medical therapy and potential issues associated with the implanted ICD, the study aims to establish facts that benefit both patients and us as physicians. This clarity should be communicated as well. It’s important to avoid stating that patients will be randomized into the group with or without a defibrillator, as nobody wants to feel they might miss out on something.”
Martin, what challenges do you expect in the course of the PROFID EHRA trial and how can you and your study team be supported?
Martin Borlich: “We will establish screening filters to have our STEMI and NSTEMI patients on our radar. At the same time, we have to inform our colleagues. We should send them a letter with the key study data. An overview on one A4 page with relevant data on the frequency of SCD, images of ICM and ICD will simplify the informed consent conversation. Many patients will be part of the randomized clinical trial (RCT) after myocardial infarction treatment. We should discuss the possibility to include patients being part of other RCT, when not influencing each other, to achieve our recruitment goals.”
Philipp, with 85 planned active study sites and more than 1,500 patients expected to be enrolled, Germany is crucial to the success of the PROFID EHRA trial. How can this ambitious goal be achieved?
Philipp Sommer: “Every single center plays a key role in this study project – of course we need a high number of enrollments but these patients still are quite frequent – ischemic cardiomyopathy with heavily impaired LV function for primary prophylaxis. We will address many German centers and if every single one of these centers contributes with some patients the goal of about 1,500 patients is very realistic.”
Philipp, what are special issues in Germany regarding the conduction of clinical trials in general and the PROFID EHRA trial in particular?
Philipp Sommer: “Like in all other European countries we have strict regulations in Germany for conducting such a study. We have to inform our patients about the current evidence for ICD in primary prophylaxis, but also on the potential downsides of this therapy. If a patient insists on getting an ICD implanted we will not force him/her to participate – but if the patient is open for both arms of this study we can include him/her and gain important insights in the current evidence for ICD in many other patients. This study will require intense discussions with our patients but will be successful without any doubts.”