Clinical trial NCT05309499: An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Iron-deficiency
Keywords: Myocardial Infarction
Iron-deficiency
WMSI
ferric carboxymaltose
left ventricular systolic function
Lead sponsor: Kazan State Medical University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: decrease in the wall motion score index
timeFrame: 1 year
Secondary outcomes:
measure: composite outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Kazan State Medical Universety
state: Tatarstan
Study officials:
References: