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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

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

Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion (NCT05759078) is a Phase 4 interventional studying Myocardial Infarction, Acute, sponsored by Wroclaw Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,000 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years; 2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation 3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation; 4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): 1. LVEF ≤50%; 2. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; 3. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; 4. Diagnosis of diabetes mellitus (also de novo diagnosis); 5. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); 6. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); 7. Not complete revascularisation or/and no reperfusion (during an index AMI); 8. History of AMI (despite an index AMI); 9. eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years. 5. Written willing to sign a consent form Who Should NOT Join This Trial: 1. Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; 2. Severe, symptomatic valve disorder; 3. Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). 4. Body weight \<50 kg; 5. Haemoglobin \<8 g/dL or \>15,5 g/dL; 6. Serum ferritin \>400 ng/mL; 7. Active gastroenteral bleeding; 8. Known hypersensitivity to any of the administered preparations; 9. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion criteria: 1. Age ≥18 years; 2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation 3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation; 4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): 1. LVEF ≤50%; 2. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; 3. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; 4. Diagnosis of diabetes mellitus (also de novo diagnosis); 5. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); 6. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); 7. Not complete revascularisation or/and no reperfusion (during an index AMI); 8. History of AMI (despite an index AMI); 9. eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years. 5. Written informed consent Exclusion criteria: 1. Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; 2. Severe, symptomatic valve disorder; 3. Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). 4. Body weight \<50 kg; 5. Haemoglobin \<8 g/dL or \>15,5 g/dL; 6. Serum ferritin \>400 ng/mL; 7. Active gastroenteral bleeding; 8. Known hypersensitivity to any of the administered preparations; 9. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; 10. 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; 11. Documented liver diseases; 12. 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; 13. Pregnancy or lactation; 14. 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.

Treatments Being Tested

DRUG

Ferinject

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.

DRUG

Sodium Chloride 0.9% Inj

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).

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Vitamed Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
Gorlice, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. J. Dietla w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu
Nowy Targ, Lesser Poland Voivodeship, Poland
Medicome Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, Poland
Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie
Tarnów, Lesser Poland Voivodeship, Poland
Zespół Opieki Zdrowotnej w Kłodzku
Kłodzko, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Lower Silesian Voivodeship, Poland
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
Wroclaw, Lower Silesian Voivodeship, Poland
Wielospecjalistyczny Szpital SP ZOZ w Zgorzelcu
Zgorzelec, Lower Silesian Voivodeship, Poland
4Cardia Sp. z o.o.
Kraśnik, Lublin Voivodeship, Poland
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
Lublin, Lublin Voivodeship, Poland
Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.
Nałęczów, Lublin Voivodeship, Poland
Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.
Zielona Góra, Lubusz Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, Poland
Mazowiecki Szpital Bródnowski Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05759078), the sponsor (Wroclaw Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05759078 clinical trial studying?

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) … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05759078?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05759078?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05759078. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05759078. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.