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

NCT05309499 | Completed Results

• 1 other identifier: BC2
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Iron-deficiency

Keywords

Myocardial Infarction; Iron-deficiency; WMSI; ferric carboxymaltose; left ventricular systolic function

Outcome Measures

Primary Outcomes (1)

• Decrease in the Wall Motion Score Index

  Using a standard transthoracic echocardiography sequence, each myocardial segment is assigned a score from 1 to 3. we used the 16 segment model of myocardial segmentation Each segment is then scored, using the following criteria: normokinesia (1 point) normal wall thickening and endocardial excursion hypokinesia (2 points) reduced wall thickening, reduced endocardial excursion akinesia (3 points) The wall motion score index is then calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). A WMSI of 1.0 (16/16) is considered normokinetic, and correlates with a CMRI calculated ejection fraction of 64%, whereas a WMSI of 3.0 correlates with an ejection fraction of 12% and is considered akinetic. There are no spetial units of measure for it.

  1 year

Secondary Outcomes (1)

• Composite Outcome

  1 year

Study Arms (3)

FCM group

ACTIVE COMPARATOR

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

Ferrous sulphate group

ACTIVE COMPARATOR

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

Drug: ferrous sulphate

Group with normal iron status

NO INTERVENTION

Patiants with normal iron status

Interventions

ferric carboxymaltose DRUG

ferric carboxymaltose is i.v. iron, 99 patiants will be randomised to this group

FCM group

ferrous sulphate DRUG

ferrous sulphate is oral iron, 100 patiants will be randomised to this group

Ferrous sulphate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kazan State Medical University: lead

Study Sites (1)

Kazan State Medical Universety

Kazan', Tatarstan Republic, 420012, Russia

Location

MeSH Terms

Conditions

Myocardial Infarction; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; ferrous sulfate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Niiaz Khasanov
• Organization: Kazan State medical Universety

dilyara_khastieva@mail.ru

+79050204407

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD student

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: December 5, 2021
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: January 5, 2026
• Results First Posted: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)