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

• Status: Recruiting
• Trial end date: 2024-12-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kazan State Medical University

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 <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 Criteria:

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.