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RECRUITING

NCT05759078

PHASE4

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

Sponsor: Wroclaw Medical University

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2022-09-22

Completion Date

2026-12-31

Last Updated

2025-07-30

Healthy Volunteers

Conditions

Myocardial Infarction, Acute

Interventions

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).

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.

Locations (43)

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

Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

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

Kędzierzyn-Koźle, Opole Voivodeship, Poland

Centrum Kardiologii w Kluczborku Scanmed S.A.

Kluczbork, Opole Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, Poland

Centrum Opieki Medycznej w Jarosławiu

Jarosław, Podkarpackie Voivodeship, Poland

Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie

Krosno, Podkarpackie Voivodeship, Poland

Uniwersyteckim Centrum Kliniczne w Gdańsku

Gdansk, Pomeranian Voivodeship, Poland

Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie

Sztum, Pomeranian Voivodeship, Poland

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

Słupsk, Pomeranian Voivodeship, Poland

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

Bielsko-Biala, Silesian Voivodeship, Poland

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

Tychy, Silesian Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, West Pomeranian Voivodeship, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Wojewódzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

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

Przasnysz, Poland

Wojewódzki Szpital im. Św. Ojca Pio

Przemyśl, Poland

Szpital Specjalistyczny Ducha Świętego w Sandomierzu

Sandomierz, Poland

Medicover Sp z o.o.

Warsaw, Poland

Szpital Specjalistyczny w Zabrzu Sp. z o.o.

Zabrze, Poland

Śląskie Centrum Chorób Serca w Zabrzu

Zabrze, Poland

Nzoz Salusmed

Lodz, Łódź Voivodeship, Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Łódź Voivodeship, Poland

Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro

Zgierz, Łódź Voivodeship, Poland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (43)