Actively Recruiting
Effect of Intravenous Ferric Carboxymaltose on Mortality, Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial Infarction Prevention of Cardiovascular Death, Heart Failure Events, and Quality of Life Deterioration with Intravenous Ferric Carboxymaltose
Led by Wroclaw Medical University · Updated on 2025-07-30
1000
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared with a placebo on death risk, heart failure events, NT-proBNP levels, and quality of life in patients who recently had an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess these outcomes over a follow-up period ranging from 8 to 36 months. Participants are randomly assigned to receive either an intravenous 15-minute infusion of 1000 mg FCM diluted in saline or a placebo infusion of saline alone. The first dose is given on the day of randomization, with follow-up visits at 4, 8, 12, 18, 24, and 30 months to reassess participants and possibly repeat treatment if safety criteria are met. During the study, participants undergo evaluations including monitoring of death rates, heart failure events such as unplanned hospitalizations or emergency visits, changes in NT-proBNP concentration, and quality of life measured by the EQ-5D questionnaire. Safety and treatment effects are tracked throughout the follow-up period, which can last up to 36 months from the start of participation.
CONDITIONS
Brief 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 28 days before randomisation
- Iron deficiency defined as transferrin saturation less than 20% within 28 days before randomisation
- Presence of at least one of the following factors confirmed within 28 days before randomisation: LVEF ≤50%, NT-proBNP ≥400 pg/mL (sinus rhythm) or ≥800 pg/mL (atrial fibrillation), clinical signs of congestion needing intravenous loop diuretics, diabetes mellitus, atrial fibrillation, multivessel coronary disease, incomplete revascularisation or no reperfusion during index AMI, history of previous AMI, or estimated glomerular filtration rate below 60 mL/min/1.73m2
- Written informed consent
You will not qualify if you...
- Body temperature over 38°C or any infection needing antibiotics within 48 hours before randomisation
- Severe symptomatic valve disorder
- Urgent hospitalization or surgery within 4 weeks before randomisation
- Body weight under 50 kg
- Hemoglobin less than 8 g/dL or greater than 15.5 g/dL
- Serum ferritin over 400 ng/mL
- Active gastrointestinal bleeding
- Known allergy to study preparations
- Treatment with erythropoiesis stimulating factors, intravenous iron, or blood transfusion within 6 months before randomisation
- Active malignancy or cancer not in 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
- Pregnancy or breastfeeding
- Conditions preventing study compliance including substance abuse or addiction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months
Participants receive an intravenous infusion of either Ferric Carboxymaltose or placebo at randomisation, followed by ongoing treatment and assessments.
7 visits (in-person) including the randomisation visit and follow-ups at 4, 8, 12, 18, 24, and 30 months
Duration - Up to 6 months after last treatment visit
Participants are monitored for safety, mortality, cardiovascular events, and quality of life after treatment.
Visits coincide with the last treatment visits up to 36 months total follow-up
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
J
Julia Raińczuk
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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