Tests intravenous iron after a recent heart attack in people with low iron
Tests intravenous iron versus saline placebo in adults with low iron after heart attack.
Plain-language title generated from the registry record
Registry title: Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Key facts
- Where
- Bielsko-Biala, Bydgoszcz, Chrzanów, Gdansk, Gorlice, Grudziądz, Jarosław, Kędzierzyn-Koźle, Kłodzko, Kluczbork, Krakow, Kraśnik, Krosno, Legnica, Lodz, Lublin, Nałęczów, Nowy Targ, Opole, Oswiecim, Przasnysz, Przemyśl, Sandomierz, Słupsk, Szczecin, Sztum, Tarnów, Torun, Tychy, Warsaw, Wroclaw, Zabrze, Zgierz, Zgorzelec, and Zielona Góra, PolandSee the 43 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a heart attack in the last 4 weeks and have iron deficiency. They also need at least 3 of several listed heart-risk factors.
- Age
- 18 to 90 years
- Sex
- Men and women can join.
- Disease stage
- Heart attack (STEMI or NSTEMI) up to 4 weeks (28 days) before joining. At least 3 listed risk factors are needed, including at least one of: LVEF ≤50%, raised NT-proBNP, or signs of fluid overload needing IV loop diuretic.
- Earlier treatment
- Cannot have had treatment with erythropoiesis stimulating factors, IV iron or a blood transfusion in the 6 months before joining.
- Biomarker or test result
- Iron deficiency shown by transferrin saturation (TSAT) below 20%, measured within 4 weeks before joining.
Main reasons for not taking part
- Fever above 38 °C (100.4 °F) or an infection needing antibiotics in the last 48 hours
- Severe valve disease with symptoms
- Body weight under 50 kg (110 lb)
- Haemoglobin under 8 g/dL or over 15,5 g/dL, or serum ferritin over 400 ng/mL
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT05759078, who can take part
Where in Poland
- Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-BiałejBielsko-Biala, PolandContact: Marta Duda-SikułaTaking people
- Vitamed BydgoszczBydgoszcz, PolandContact: Marta Duda-SikułaTaking people
- Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-NaczynioweChrzanów, PolandContact: Marta Duda-SikułaTaking people
- Uniwersyteckim Centrum Kliniczne w GdańskuGdansk, PolandContact: Marta Duda-SikułaTaking people
- Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w GorlicachGorlice, PolandContact: Marta Duda-SikułaNo longer taking part
- Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w GrudziądzuGrudziądz, PolandContact: Marta Duda-SikułaTaking people
- Centrum Opieki Medycznej w JarosławiuJarosław, PolandContact: Marta Duda-SikułaTaking people
- Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie KoźluKędzierzyn-Koźle, PolandContact: Marta Duda-SikułaTaking people
- Zespół Opieki Zdrowotnej w KłodzkuKłodzko, PolandContact: Marta Duda-SikułaTaking people
- Centrum Kardiologii w Kluczborku Scanmed S.A.Kluczbork, PolandContact: Marta Duda-SikułaTaking people
- Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w KrakowieKrakow, PolandContact: Marta Duda-SikułaTaking people
- Szpital Specjalistyczny im. J. Dietla w KrakowieKrakow, PolandContact: Marta Duda-SikułaTaking people
- 4Cardia Sp. z o.o.Kraśnik, PolandContact: Marta Duda-SikułaNo longer taking part
- Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w KrośnieKrosno, PolandContact: Marta Duda-SikułaNo longer taking part
- Wojewodzki Szpital Specjalistyczny w LegnicyLegnica, PolandContact: Marta Duda-SikułaTaking people
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziLodz, PolandContact: Marta Duda-SikułaTaking people
- Nzoz SalusmedLodz, PolandContact: Marta Duda-SikułaTaking people
- 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w LublinieLublin, PolandContact: Marta Duda-SikułaNo longer taking part
- Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.Nałęczów, PolandContact: Marta Duda-SikułaNo longer taking part
- Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym TarguNowy Targ, PolandContact: Marta Duda-SikułaNo longer taking part
- Uniwersytecki Szpital Kliniczny w OpoluOpole, PolandContact: Marta Duda-SikułaTaking people
- Medicome Sp. z o.o.Oswiecim, PolandContact: Marta Duda-SikułaTaking people
- Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. dr Wojciecha Oczko w PrzasnyszuPrzasnysz, PolandContact: Marta Duda-SikułaTaking people
- Wojewódzki Szpital im. św. Ojca PioPrzemyśl, PolandContact: Marta Duda-SikułaTaking people
- Szpital Specjalistyczny Ducha Świętego w SandomierzuSandomierz, PolandContact: Marta Duda-SikułaNo longer taking part
- Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.Słupsk, PolandContact: Marta Duda-SikułaNo longer taking part
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w SzczecinieSzczecin, PolandContact: Marta Duda-SikułaTaking people
- Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w SztumieSztum, PolandContact: Marta Duda-SikułaTaking people
- Szpital Wojewódzki im. św. Łukasza SP ZOZ w TarnowieTarnów, PolandContact: Marta Duda-SikułaNo longer taking part
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, PolandContact: Marta Duda-SikułaTaking people
- Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w TychachTychy, PolandContact: Marta Duda-SikułaTaking people
- Mazowiecki Szpital Brodnowski Sp. z o.o.Warsaw, PolandContact: Marta Duda-SikułaTaking people
- Medicover Sp z o.o.Warsaw, PolandContact: Marta Duda-SikułaTaking people
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandContact: Marta Duda-SikułaTaking people
- Centralny Szpital Kliniczny MSWiA w WarszawieWarsaw, PolandContact: Marta Duda-SikułaNo longer taking part
- Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny RatunkowejWroclaw, PolandContact: Marta Duda-SikułaTaking people
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuWroclaw, PolandContact: Marta Duda-SikułaTaking people
- 4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZWroclaw, PolandContact: Marta Duda-SikułaNo longer taking part
- Śląskie Centrum Chorób Serca w ZabrzuZabrze, PolandContact: Marta Duda-SikułaTaking people
- Szpital Specjalistyczny w Zabrzu Sp. z o.o.Zabrze, PolandContact: Marta Duda-SikułaTaking people
- Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-ProZgierz, PolandContact: Marta Duda-SikułaNo longer taking part
- Wielospecjalistyczny Szpital SP ZOZ w ZgorzelcuZgorzelec, PolandContact: Marta Duda-SikułaTaking people
- Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.Zielona Góra, PolandContact: Marta Duda-SikułaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Wroclaw Medical University
- Trial code
- NCT05759078
- Record updated
- 30 July 2025
- Original description
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.Read full original descriptionShow less
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
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).
Inclusion: 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; Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):; LVEF ≤50%; NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; Diagnosis of diabetes mellitus (also de novo diagnosis); Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); Not complete revascularisation or/and no reperfusion (during an index AMI); History of AMI (despite an index AMI); eGFR <60 mL/min/1.73m2; 1. Age ≥70 years; Written informed consent.
Exclusion: Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation); Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia; Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit; Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction; Severe, symptomatic valve disorder; Active gastroenteral bleeding; Known hypersensitivity to any of the administered preparations; Documented liver diseases; Haemoglobin <8 g/dL or >15,5 g/dL; Serum ferritin >400 ng/mL; Body weight <50 kg; Pregnancy or lactation.