Actively Recruiting
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Led by Wroclaw Medical University · Updated on 2025-07-30
1000
Participants Needed
43
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of acute myocardial infarction (STEMI or NSTEMI) within 4 weeks before randomisation
- Presence of iron deficiency with transferrin saturation below 20% assessed within 4 weeks before randomisation
- Presence of at least 3 of the following factors confirmed within 4 weeks before randomisation: left ventricular ejection fraction 50% or less; NT-proBNP 400 pg/mL or higher for sinus rhythm or 800 pg/mL or higher for atrial fibrillation; clinical signs of congestion requiring intravenous loop diuretic use; diagnosis of diabetes mellitus; diagnosis of atrial fibrillation; multivessel coronary disease; incomplete revascularisation or no reperfusion during index AMI; history of previous AMI; estimated glomerular filtration rate below 60 mL/min/1.73m2
- Written informed consent
You will not qualify if you...
- Body temperature over 38 degrees Celsius or infection requiring antibiotics within 48 hours before randomisation
- Severe symptomatic valve disorder
- Urgent hospitalization or invasive procedure requiring hospitalization within 4 weeks before randomisation
- Body weight less than 50 kg
- Hemoglobin less than 8 g/dL or greater than 15.5 g/dL
- Serum ferritin greater than 400 ng/mL
- Active gastrointestinal bleeding
- Known hypersensitivity to study medications
- Treatment with erythropoiesis stimulating factors, intravenous iron therapy, or blood transfusion within 6 months before randomisation
- Known active malignancy or malignancy not in stable remission for at least 3 years except certain skin or cervical conditions
- Documented liver disease
- Participation in another drug or device trial within 3 months before randomisation or 5 half-lives of the drug
- Pregnancy or breastfeeding
- Any condition preventing adherence to the study protocol, including substance abuse or addiction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
Vitamed Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
Actively Recruiting
2
Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
Actively Recruiting
3
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
4
Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, Poland, 32-500
Actively Recruiting
5
Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
Gorlice, Lesser Poland Voivodeship, Poland, 38-300
Terminated
6
Szpital Specjalistyczny im. J. Dietla w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 31-121
Actively Recruiting
7
Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu
Nowy Targ, Lesser Poland Voivodeship, Poland, 34-400
Terminated
8
Medicome Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
Actively Recruiting
9
Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Terminated
10
Zespół Opieki Zdrowotnej w Kłodzku
Kłodzko, Lower Silesian Voivodeship, Poland, 57-300
Actively Recruiting
11
Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
12
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
Terminated
13
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
Wroclaw, Lower Silesian Voivodeship, Poland, 54-049
Actively Recruiting
14
Wielospecjalistyczny Szpital SP ZOZ w Zgorzelcu
Zgorzelec, Lower Silesian Voivodeship, Poland, 59-900
Actively Recruiting
15
4Cardia Sp. z o.o.
Kraśnik, Lublin Voivodeship, Poland, 23-204
Terminated
16
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
Lublin, Lublin Voivodeship, Poland, 20-049
Terminated
17
Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.
Nałęczów, Lublin Voivodeship, Poland, 24-140
Terminated
18
Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.
Zielona Góra, Lubusz Voivodeship, Poland, 65-046
Actively Recruiting
19
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, Poland, 02-507
Terminated
20
Mazowiecki Szpital Bródnowski Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland, 03-242
Actively Recruiting
21
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland, 04-349
Actively Recruiting
22
Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu
Kędzierzyn-Koźle, Opole Voivodeship, Poland, 47-200
Actively Recruiting
23
Centrum Kardiologii w Kluczborku Scanmed S.A.
Kluczbork, Opole Voivodeship, Poland, 46-200
Actively Recruiting
24
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, Poland, 45-401
Actively Recruiting
25
Centrum Opieki Medycznej w Jarosławiu
Jarosław, Podkarpackie Voivodeship, Poland, 37-500
Actively Recruiting
26
Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie
Krosno, Podkarpackie Voivodeship, Poland, 38-400
Terminated
27
Uniwersyteckim Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
28
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie
Sztum, Pomeranian Voivodeship, Poland, 82-400
Actively Recruiting
29
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Pomeranian Voivodeship, Poland, 76-200
Terminated
30
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
Bielsko-Biala, Silesian Voivodeship, Poland, 43-316
Actively Recruiting
31
Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach
Tychy, Silesian Voivodeship, Poland, 43-100
Actively Recruiting
32
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, West Pomeranian Voivodeship, Poland, 70-111
Actively Recruiting
33
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Actively Recruiting
34
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, Poland
Actively Recruiting
35
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. dr Wojciecha Oczko w Przasnyszu
Przasnysz, Poland
Actively Recruiting
36
Wojewódzki Szpital im. Św. Ojca Pio
Przemyśl, Poland
Actively Recruiting
37
Szpital Specjalistyczny Ducha Świętego w Sandomierzu
Sandomierz, Poland
Terminated
38
Medicover Sp z o.o.
Warsaw, Poland
Actively Recruiting
39
Szpital Specjalistyczny w Zabrzu Sp. z o.o.
Zabrze, Poland
Actively Recruiting
40
Śląskie Centrum Chorób Serca w Zabrzu
Zabrze, Poland
Actively Recruiting
41
Nzoz Salusmed
Lodz, Łódź Voivodeship, Poland, 91-002
Actively Recruiting
42
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Łódź Voivodeship, Poland, 92-213
Actively Recruiting
43
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro
Zgierz, Łódź Voivodeship, Poland, 95-100
Terminated
Research Team
M
Marta Duda-Sikuła
CONTACT
J
Julia Raińczuk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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