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

Kazan State Medical University

Status: Completed

Conditions: Iron-deficiency; Myocardial Infarction

Treatments: Drug: ferrous sulphate; Drug: ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT05309499

BC2

Details and patient eligibility

About

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

Full 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.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 3 patient groups

FCM group

Active Comparator group

Description:

The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels.

Treatment:

Drug: ferric carboxymaltose

Ferrous sulphate group

Active Comparator group

Description:

100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month.

Treatment:

Drug: ferrous sulphate

Group with normal iron status

No Intervention group

Description:

Patiants with normal iron status