An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing … (NCT05309499) | Clinical Trial Compass
CompletedNot Applicable
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
Russia298 participantsStarted 2021-12-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …