Status:
COMPLETED
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
Lead Sponsor:
Kazan State Medical University
Conditions:
Myocardial Infarction
Iron-deficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 randomi...
Eligibility Criteria
Inclusion
- 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 \<15,0 g/dl and serum iron \<12 µmol/l on screening visit.
- Serum ferritin \<100 μg/L, or 100-299 μg/L when transferrin saturation \<20%.
Exclusion
- Known hypersensitivity reaction to any component of ferric carboxymaltose.
- History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
- Heart failure Killip class II-IV on screening visit.
- Current or planned mechanical circulatory support or heart transplantation.
- Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>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.
Key Trial Info
Start Date :
December 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2025
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT05309499
Start Date
December 5 2021
End Date
September 15 2025
Last Update
January 5 2026
Active Locations (1)
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1
Kazan State Medical Universety
Kazan', Tatarstan Republic, Russia, 420012