An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function — OPERA-MI  

Myocardial Infarction Clinical Trial

Official title: An Open, Prospective, Randomized Study on the Efficacy of Iron Therapy Using Intravenous (IV) Iron Supplements Relative to Oral Iron Intake for Increasing Left Ventricular Systolic Function in Patients With Myocardial Infarction

Status Recruiting

Clinical Trial Summary

The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.

Clinical Trial Description

For this study an open-label prospective randomized approach is used. During the study 360 patients with or without ID, who hospitalized for myocardial infarction were signed up. Patients were randomised (1:1) to either intravenous. FCM or oral ferrous sulphate and received the treatment during hospitalisation. Patients are closely followed for 1 year. The primary outcome is a decrease in the Wall Motion Score Index value in FCM group compered to ferrous sulphate group. The main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal MI, recurrent heart failure hospitalizations. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Infarction
• Iron-deficiency
• Myocardial Infarction
• Systolic Murmurs

• NCT number: NCT05309499
• Study type: Interventional
• Source: Kazan State Medical University
• Contact: Dilyara Khastieva, MD
• Phone: +79050204407
• Email: dilyara_khastieva@mail.ru
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Completion date: December 5, 2024