The PROFID EHRA trial (NCT05665608) started in November 2023. It is 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. Until now, almost 20 clinical sites in Austria, the Czech Republic, Germany and Spain have been opened for recruitment and more than 50 patients have been enrolled. Olomouc University Hospital is so far the best recruiting study site and we had the opportunity to interview the Principal Investigator of the study site, Professor Miloš Táborský, which is also the National Coordinator of the PROFID EHRA trial in the Czech Republic.
Miloš, first of all we want to thank you for the remarkable results in the PROFID EHRA trial. You already enrolled more than 30 patients and are therefore the best recruiting study center. What is important for successful patient recruitment?
Miloš Táborský: “It is essential to create awareness about the trial. So we presented PROFID EHRA at National Cardiology Congresses in the Czech Republic and we contacted the heads of potential cardiovascular centers. In addition, we formulated newsletters and distributed them towards the electrophysiology community. It is important to transfer the image of an exclusive independent academic study without any industry influence.“
How do you effectively screen patients who are potentially suitable for inclusion in PROFID EHRA?
Miloš Táborský: “We screen all post myocardial infarction (MI) patients with left ventricular (LV) dysfunction and Ejection Fraction (EF) < 0.35% and start the treatment of heart failure in a rapid scheme according to the ESC guidelines during the end of hospitalization of the patient. The goal is to have maximally tolerated heart failure therapy within a month. I recommend to use external cardiology clinics for this and cooperate with them. 3 months after MI we invite the patient for a routine clinical check-up and review standard clinical aspects like lab, glycemia or LDL cholesterol. We perform a control echocardiography and compare the development of LVEF with the baseline value. We then invite patients with persistent LV dysfunction (EF < 0.35%) in a month and educate them about the possibility of entering the PROFID EHRA trial and carefully explain the treatment alternatives. In the fourth month after MI in this scheme, the patient who meets the inclusion criteria and is carefully informed about the PROFID EHRA trial, is asked to sign the informed consent and will then be randomised to OMT (optimal medical therapy) or OMT + ICD (implantable cardioverter-defibrillator).“
How do you effectively screen patients who are potentially suitable for inclusion in PROFID EHRA?
Miloš Táborský: “All communication with the patient must always be carried out positively and there must be enough time to explain the risk of sudden cardiac death (SCD) after MI and the possibilities of its reduction. In addition, the patient must have enough information about modern pharmacotherapy of heart failure, which includes knowledge about all 4 pillars. (editors note: The “four pillars” of heart failure therapy are the following medications: beta blockers, angiotensin receptor-neprilysin inhibitors (ARNIs), mineralcorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i).) Ideally, after the education, the patient takes the informed consent of the PROFID EHRA trial home, thinks about the pluses and minuses of the study, consults with the family, General Physician or cardiologist and at the end decides to participate.“
You are the National Coordinator of the PROFID EHRA trial in the Czech Republic. What are your expectations for patient recruitment in your country?
Miloš Táborský: “Currently, 6 cardiovascular centers in the Czech Republic would like to participate in the trial but we anticipate an expansion to at least 10 centers. Our ambitious but realistic plan is the randomisation of at least 500 patients in the PROFID EHRA trial. “