Rationale and design of the open-label, prospective, randomized study of the efficacy of intravenous versus oral iron deficiency therapy in improving left ventricular systolic function in patients with myocardial infarction (OPERA-MI)

Abstract

Aim. Iron has a protective effect on cardiomyocytes during hypoxia, while iron deficiency (ID) directly affects its function, disrupting mitochondrial respiration, reducing their contractility and relaxation. Some studies have shown that ID is a predictor of adverse outcomes in patients with acute coronary syndrome (ACS). However, the impact of ID and its treatment, quality of life and prognosis of patients with ID and myocardial infarction (MI) has not been fully established. The study aim is to determine the effectiveness of intravenous ferric carboxymaltose (FCM) compared with oral iron (ferrous sulfate) in relation to left ventricular (LV) systolic function, assessed by echocardiography.Material and methods. This open-label, prospective, randomized study includes 360 patients with or without ID who were hospitalized with acute myocardial infarction (MI). Patients with ID will be randomized (1:1) to intravenous FCM and oral ferrous sulfate therapy. Treatment in groups will be started at the time of hospitalization. Patients without ID will form the control group. The follow-up period for patients will be 1 year. The primary endpoint was a reduction in LV wall motion score index (WMSI) in the FCM group compared to the ferrous sulfate group. The key secondary endpoint is a composite endpoint of cardiovascular death, non-fatal MI and stroke, and hospitalization for decompensated heart failure.Conclusion. The OPERA-MI study will determine the effect of ID treatment with intravenous FCM compared with oral ferrous sulfate on WMSI, which reflects LV systolic function.