Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Recruiting · NCT05759078 · Interventional (participants receive a specific treatment) · Lead sponsor: Wroclaw Medical University
View the official record on ClinicalTrials.gov →Interventions studied
FerinjectSodium Chloride 0.9% Inj
What this trial is about
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).
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
43 locations listed.
- 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
- 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
- Centrum Kardiologii w Kluczborku Scanmed S.A. - Kluczbork, Opole Voivodeship, Poland
- Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu - Kędzierzyn-Koźle, 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
- 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