Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation: minimum of 8 months up to a maximum of 36 months.
Primary Study 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;
LVEF ≤50%;
Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
Severe, symptomatic valve disorder;
Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
Body weight <50 kg;
Parallel
Ferinject
DrugThe first dose of either FCM will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7). If safety criteria are not fulfilled, a patient in the active study arm will receive i.v. NaCl 0.9% during the particular visit.
Sodium Chloride 0.9% Inj
DrugThe first dose of placebo will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7).
Time to all-cause death assessed up to maximum 36-months follow-up;
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order): 1. Time to all-cause death assessed up to maximum 36-months follow-up; 2. Number of HFE assessed up to maximum 36-months follow-up; 3. Time to first HFE assessed up to maximum 36-months follow-up; 4. Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve; 5. Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve. * 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).
Number of HFE assessed up to maximum 36-months follow-up
Number of HFE
Time to first HFE assessed up to maximum 36-months follow-up
Time to first HFE
Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve
Changes in serum NT-proBNP
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)
First unplanned HF hospitalisation or unplanned visit at emergency
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model);
All unplanned HF hospitalisations and unplanned visit at emergency
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)
All unplanned HF hospitalisations and unplanned visit at emergency department
All unplanned HF hospitalisations during the follow-up (recurrent event model);
All unplanned HF hospitalisations
First unplanned CV hospitalisation or CV death during the follow-up (time-to-event model);
First unplanned CV hospitalisation or CV death during the follow-up
All unplanned CV hospitalisations and CV death during the follow-up (recurrent event model);
All unplanned CV hospitalisations and CV death during the follow-up
All unplanned CV hospitalisations during the follow-up (recurrent event model);
All unplanned CV hospitalisations during the follow-up (recurrent event model);
Non-CV death during the follow-up
Non-CV death during the follow-up
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