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

NCT05759078 | Recruiting Phase 4

• 1 other identifier: 2019/ABM/01/00081
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 43

Brief Summary

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

Myocardial Infarction, Acute

Keywords

Myocardial infarction; acute; iron deficiency; Infusion; ferric carboxymaltose

Outcome Measures

Primary Outcomes (5)

• Time to all-cause death assessed up to maximum 36-months follow-up;

  Defined as: (with an implementation of a win ratio approach in a hierarchical descending order): 1. Time to all-cause death assessed up to maximum 36-months follow-up; 2. Number of HFE assessed up to maximum 36-months follow-up; 3. Time to first HFE assessed up to maximum 36-months follow-up; 4. Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve; 5. Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve. * 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).

  up to 36 months

• Number of HFE assessed up to maximum 36-months follow-up

  Number of HFE

  up to 36 months

• Time to first HFE assessed up to maximum 36-months follow-up

  Time to first HFE

  up to 36 months

• Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve

  Changes in serum NT-proBNP

  up to 36 months

• Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve

  Changes in quality of life

  up to 36 months

Secondary Outcomes (5)

• First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)

  up to 36 months

• All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model);

  up to 36 months

• All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)

  up to 36 months

• All unplanned HF hospitalisations during the follow-up (recurrent event model);

  up to 36 months

• CV death during the follow-up

  up to 36 months

Other Outcomes (9)

• First unplanned CV hospitalisation or CV death during the follow-up (time-to-event model);

  up to 36 months

• All unplanned CV hospitalisations and CV death during the follow-up (recurrent event model);

  up to 36 months

• All unplanned CV hospitalisations during the follow-up (recurrent event model);

  up to 36 months

Study Arms (2)

Active

EXPERIMENTAL

an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9%

Drug: Ferinject

Placebo

PLACEBO COMPARATOR

70 mL of i.v. NaCl 0.9% infusion

Drug: Sodium Chloride 0.9% Inj

Interventions

Ferinject DRUG

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.

Active

Sodium Chloride 0.9% Inj DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
• Severe, symptomatic valve disorder;
• Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
• Body weight \<50 kg;
• Haemoglobin \<8 g/dL or \>15,5 g/dL;
• Serum ferritin \>400 ng/mL;
• Active gastroenteral bleeding;
• Known hypersensitivity to any of the administered preparations;
• 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;
• Documented liver diseases;
• 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;
• Pregnancy or lactation;
• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (43)

Vitamed Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

RECRUITING

Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

RECRUITING

Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe

Chrzanów, Lesser Poland Voivodeship, 32-500, Poland

RECRUITING

Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach

Gorlice, Lesser Poland Voivodeship, 38-300, Poland

TERMINATED

Szpital Specjalistyczny im. J. Dietla w Krakowie

Krakow, Lesser Poland Voivodeship, 31-121, Poland

RECRUITING

Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu

Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland

TERMINATED

Medicome Sp. z o.o.

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

TERMINATED

Zespół Opieki Zdrowotnej w Kłodzku

Kłodzko, Lower Silesian Voivodeship, 57-300, Poland

RECRUITING

Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

TERMINATED

Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej

Wroclaw, Lower Silesian Voivodeship, 54-049, Poland

RECRUITING

Wielospecjalistyczny Szpital SP ZOZ w Zgorzelcu

Zgorzelec, Lower Silesian Voivodeship, 59-900, Poland

RECRUITING

4Cardia Sp. z o.o.

Kraśnik, Lublin Voivodeship, 23-204, Poland

TERMINATED

1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie

Lublin, Lublin Voivodeship, 20-049, Poland

TERMINATED

Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.

Nałęczów, Lublin Voivodeship, 24-140, Poland

TERMINATED

Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.

Zielona Góra, Lubusz Voivodeship, 65-046, Poland

RECRUITING

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

TERMINATED

Mazowiecki Szpital Bródnowski Sp. z o.o.

Warsaw, Masovian Voivodeship, 03-242, Poland

RECRUITING

Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 04-349, Poland

RECRUITING

Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu

Kędzierzyn-Koźle, Opole Voivodeship, 47-200, Poland

RECRUITING

Centrum Kardiologii w Kluczborku Scanmed S.A.

Kluczbork, Opole Voivodeship, 46-200, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, 45-401, Poland

RECRUITING

Centrum Opieki Medycznej w Jarosławiu

Jarosław, Podkarpackie Voivodeship, 37-500, Poland

RECRUITING

Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie

Krosno, Podkarpackie Voivodeship, 38-400, Poland

TERMINATED

Uniwersyteckim Centrum Kliniczne w Gdańsku

Gdansk, Pomeranian Voivodeship, 80-952, Poland

RECRUITING

Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie

Sztum, Pomeranian Voivodeship, 82-400, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.

Słupsk, Pomeranian Voivodeship, 76-200, Poland

TERMINATED

Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej

Bielsko-Biala, Silesian Voivodeship, 43-316, Poland

RECRUITING

Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach

Tychy, Silesian Voivodeship, 43-100, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

RECRUITING

Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. dr Wojciecha Oczko w Przasnyszu

Przasnysz, Poland

RECRUITING

Wojewódzki Szpital im. Św. Ojca Pio

Przemyśl, Poland

RECRUITING

Szpital Specjalistyczny Ducha Świętego w Sandomierzu

Sandomierz, Poland

TERMINATED

Medicover Sp z o.o.

Warsaw, Poland

RECRUITING

Szpital Specjalistyczny w Zabrzu Sp. z o.o.

Zabrze, Poland

RECRUITING

Śląskie Centrum Chorób Serca w Zabrzu

Zabrze, Poland

RECRUITING

Nzoz Salusmed

Lodz, Łódź Voivodeship, 91-002, Poland

RECRUITING

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Łódź Voivodeship, 92-213, Poland

RECRUITING

Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro

Zgierz, Łódź Voivodeship, 95-100, Poland

TERMINATED

Related Links

• INFERRCT study website

MeSH Terms

Conditions

Myocardial Infarction; Iron Deficiencies

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Piotr Ponikowski

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Duda-Sikuła

CONTACT

717840696; marta.duda-sikula@umw.edu.pl

Julia Raińczuk

CONTACT

717840697; julia.rainczuk@umw.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A drip will be prepared by unblinded personnel using masked bottle, light brown lines for infusion, and administered immediately after preparation using a special curtain (screen).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 8, 2023
• Study Start: September 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (43)