N/A
N=298
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
Myocardial Infarction · Iron-deficiency
Bottom Line
View on ClinicalTrials.gov: NCT05309499 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Decrease in the Wall Motion Score Index — 53; 58; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ferric carboxymaltose (Drug); ferrous sulphate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kazan State Medical University
- Primary completion
- Sep 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the Wall Motion Score Index |
53; 58; 46 | — |
| SECONDARY Composite Outcome |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
- Hemoglobin >9.0 g/dL and 3 times the upper limit of normal range).
- Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- Active gastrointestinal bleeding.
- Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- Inability to return for follow up visits within the necessary period of time.
Data sourced from ClinicalTrials.gov (NCT05309499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.