Condition: Myocardial Infarction, Acute · Sponsor: Wroclaw Medical University
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).
This description comes directly from the study's public registry record.
Marta Duda-Sikuła · 717840696 · marta.duda-sikula@umw.edu.pl
Julia Raińczuk · 717840697 · julia.rainczuk@umw.edu.pl
Always discuss trial participation with your own doctor first.
| Vitamed Bydgoszcz | Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland | Recruiting |
| Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu | Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland | Recruiting |
| Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun, Kuyavian-Pomeranian Voivodeship, Poland | Recruiting |
| Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe | Chrzanów, Lesser Poland Voivodeship, Poland | Recruiting |
| Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach | Gorlice, Lesser Poland Voivodeship, Poland | Terminated |
| Szpital Specjalistyczny im. J. Dietla w Krakowie | Krakow, Lesser Poland Voivodeship, Poland | Recruiting |
| Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu | Nowy Targ, Lesser Poland Voivodeship, Poland | Terminated |
| Medicome Sp. z o.o. | Oświęcim, Lesser Poland Voivodeship, Poland | Recruiting |
| Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie | Tarnów, Lesser Poland Voivodeship, Poland | Terminated |
| Zespół Opieki Zdrowotnej w Kłodzku | Kłodzko, Lower Silesian Voivodeship, Poland | Recruiting |
| Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Wroclaw, Lower Silesian Voivodeship, Poland | Recruiting |
| 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ | Wroclaw, Lower Silesian Voivodeship, Poland | Terminated |
+ 31 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05759078