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

Myocardial Infarction Clinical Trial

— OPERA-MI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309499
• Other study ID #: BC2
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 5, 2024

Study information

• Verified date: April 2022
• Source: Kazan State Medical University
• Contact: Dilyara Khastieva, MD
• Phone: +79050204407
• Email: dilyara_khastieva[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Infarction
• Iron-deficiency
• Myocardial Infarction
• Systolic Murmurs

Intervention

Drug:
• ferric carboxymaltose
ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group
• ferrous sulphate
ferrous sulphate is oral iron, 121patiants will be randomised to this group

Locations

Country	Name	City	State
Russian Federation	Kazan State Medical Universety	Kazan	Tatarstan

Sponsors (1)

Lead Sponsor	Collaborator
Kazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in the wall motion score index	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.	1 year
Secondary	composite outcome	composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.	1 year