NCT05309499

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Kazan State Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myocardial Infarction
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	ferric carboxymaltose	ferric carboxymaltose is i.v. iron, 99 patiants will be randomised to this group
DRUG	ferrous sulphate	ferrous sulphate is oral iron, 100 patiants will be randomised to this group

Timeline

• Start date: 2021-12-05
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2022-04-04
• Last updated: 2026-01-05
• Results posted: 2026-01-05

Locations

1 site across 1 country: Russia