Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
Objective: Primary: Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE\*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). \*HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
• Age ≥18 years;
• Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation
• Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation;
• Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):
‣ LVEF ≤50%;
⁃ NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation;
⁃ Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use;
⁃ Diagnosis of diabetes mellitus (also de novo diagnosis);
⁃ Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);
⁃ Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);
⁃ Not complete revascularisation or/and no reperfusion (during an index AMI);
⁃ History of AMI (despite an index AMI);
⁃ eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years.
• Written informed consent