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

Sponsor

Kazan State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05309499

Collaborator

(none)

360

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Iron-deficiency	Drug: ferric carboxymaltose Drug: ferrous sulphate	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 5, 2021

Anticipated Primary Completion Date :

Dec 5, 2023

Anticipated Study Completion Date :

Dec 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FCM group 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.	Drug: ferric carboxymaltose ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group
Active Comparator: Ferrous sulphate group 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month.	Drug: ferrous sulphate ferrous sulphate is oral iron, 121patiants will be randomised to this group
No Intervention: Group with normal iron status Patiants with normal iron status

Arm

Intervention/Treatment

Active Comparator: FCM group

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.

Drug: ferric carboxymaltose

ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group

Active Comparator: Ferrous sulphate group

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

Drug: ferrous sulphate

ferrous sulphate is oral iron, 121patiants will be randomised to this group

No Intervention: Group with normal iron status

Patiants with normal iron status

Outcome Measures

Primary Outcome Measures

decrease in the wall motion score index [1 year]
WMSI reflects the left ventricular systolic function and calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). There are no spetial units of measure for it.

Secondary Outcome Measures

composite outcome [1 year]
composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.