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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,000
The 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.
The 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).
Vitamed Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
RECRUITINGWojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, Poland
RECRUITINGPolsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, Poland
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).
Time frame: up to 36 months
Number of HFE assessed up to maximum 36-months follow-up
Number of HFE
Time frame: up to 36 months
Time to first HFE assessed up to maximum 36-months follow-up
Time to first HFE
Time frame: up to 36 months
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
Time frame: up to 36 months
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
Changes in quality of life
Time frame: up to 36 months
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
Time frame: up to 36 months
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
Time frame: up to 36 months
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
Time frame: up to 36 months
All unplanned HF hospitalisations during the follow-up (recurrent event model);
All unplanned HF hospitalisations
Time frame: up to 36 months
CV death during the follow-up
CV death
Time frame: up to 36 months
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Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
Gorlice, Lesser Poland Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
RECRUITINGPodhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu
Nowy Targ, Lesser Poland Voivodeship, Poland
TERMINATEDMedicome Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, Poland
RECRUITINGSzpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie
Tarnów, Lesser Poland Voivodeship, Poland
TERMINATEDZespół Opieki Zdrowotnej w Kłodzku
Kłodzko, Lower Silesian Voivodeship, Poland
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