Study on the Effects of Ferric Carboxymaltose on Heart Health and Quality of Life in Patients with Recent Heart Attack and Iron Deficiency

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What is this study about?

This clinical trial is focused on patients who have recently experienced a myocardial infarction, commonly known as a heart attack, and are also dealing with iron deficiency. The study is investigating the effects of a treatment called ferric carboxymaltose, which is a form of iron given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to evaluate how this treatment affects the risk of death, heart-related health issues, and the overall quality of life in these patients.

Participants in the study will receive either the ferric carboxymaltose treatment or a placebo. The study will monitor the participants over a period of up to 36 months. During this time, researchers will track various health outcomes, including the number of heart failure events, which are instances where the heart does not pump blood as well as it should, and changes in a specific blood marker called NT-proBNP, which is often elevated in heart failure. Additionally, the study will assess changes in the participants’ quality of life using a questionnaire known as EQ-5D.

The study aims to provide valuable insights into whether treating iron deficiency with ferric carboxymaltose can improve survival rates and reduce heart-related complications in patients who have recently had a heart attack. By understanding these effects, the study hopes to contribute to better management and treatment strategies for individuals with these health conditions.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, recent heart attack, and iron deficiency.

Written consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted to evaluate health status, including heart function and iron levels.

This assessment helps determine the starting point for the study.

3 treatment administration

The treatment involves the administration of ferric carboxymaltose through an intravenous infusion.

A solution of 0.9% sodium chloride is used as a carrier for the infusion.

The frequency and dosage of the infusion are determined by the study protocol.

4 follow-up assessments

Regular follow-up assessments are conducted to monitor health outcomes, including heart function and quality of life.

These assessments occur periodically over a follow-up period of up to 36 months.

5 evaluation of outcomes

The study evaluates the effect of the treatment on mortality, heart failure events, and quality of life.

Outcomes are measured using specific criteria, such as changes in heart-related biomarkers and quality of life questionnaires.

6 completion of study

The study concludes after the follow-up period, with a final assessment to evaluate the overall impact of the treatment.

Participants receive information about the study results and any relevant health recommendations.

Who Can Join the Study?

Must be at least 18 years old.
Must have had a recent heart attack, either STEMI or NSTEMI, within the last 4 weeks (28 days).
Must have iron deficiency, which means low levels of iron in the body, confirmed by a test called transferrin saturation (TSAT) showing less than 20% within the last 4 weeks.
Must have at least 3 of the following factors confirmed within the last 4 weeks:
- LVEF (Left Ventricular Ejection Fraction) of 50% or less, which is a measure of how well the heart pumps blood.
- NT-proBNP levels of 400 pg/mL or more for those with normal heart rhythm, or 800 pg/mL or more for those with a condition called atrial fibrillation.
- Signs of fluid buildup in the body, needing treatment with a type of medicine called i.v. loop diuretics.
- Diagnosis of diabetes mellitus, which is a condition where blood sugar levels are too high.
- Diagnosis of atrial fibrillation, a type of irregular heartbeat, at any time in the past or newly diagnosed.
- Multivessel coronary disease, which means having blockages in more than one heart artery.
- Not having complete treatment to open blocked heart arteries during the recent heart attack.
- History of a previous heart attack, in addition to the recent one.
- eGFR (estimated Glomerular Filtration Rate) less than 60 mL/min/1.73m², which is a measure of kidney function.
- Age 70 years or older.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have had a recent myocardial infarction (heart attack) associated with iron deficiency cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Mazowiecki Szpital Brodnowski Sp. z o.o.	Warsaw	Poland
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej	Wroclaw	Poland
Osrodek Kardiologii Inwazyjnej Ikardia Sp. z o.o.	Naleczow	Poland
Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Wojewodzki Szpital Specjalistyczny W Legnicy	Legnica	Poland
NZOZ SALUSMED	Lodz	Poland
Mezwsvamv Ipmatvkkho Cqnwjxkx Shyozort Sso z osym	Warsaw	Poland
Rcjatlzpuv Sbwkvgg Sjooancysdznoqk Ivy Dfc Wfepmqrxjp Bgiryhhcrxrk	Grudziadz	Poland
Cjwkorz Oljapm Maspvtobk	Jaroslaw	Poland
Sloxvtg Uzbahoehiadsf Iniffyl Kmtkry Muurjfbxmkyaodn W Zxlbngeq Gatdu Srl z oo os	Zielona Gora	Poland
Sttmida Scse	Kluczbork	Poland
Syqkvvm Spolxgjnhnwczjh W Zznxww Sny z ofeh	Zabrze	Poland
Wdyckrgwcxskxcwjjrnh Sagelmb Sumgl W Zjqbwijwf	Zgorzelec	Poland
Zueyzo Owrjre Zefvleojoi W Kapwjic	Klodzko	Poland
Sycbjdl Ssftmlsxdesxjsz Iqiqsvptmql W Kastplfy	Cracow	Poland
Sktltclenzz Phwoxpqtb Zwusuo Zyrwdxtf Osmsxl Zkffgcaicx W Pxwxaowvoe	Przasnysz	Poland
Sbjvhji Szbtstkedsxsbkt Djuei Suneeieo W Sarkqxmqrfc	Sandomierz	Poland
Ujqvostsiffwo Suzivis Krftwmius Nd 2 Ple W Slrjyurrtd	Szczecin	Poland
Uzlvwlkiydliau Cqnvspe Kjdhvxfjo	Gdansk	Poland
Wloiuzuotx Smrzstv Izj Shiwmqz Ptc W Phnlhwerv	Przemysl	Poland
Mezhbgkd Sbl z ovft	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.03.2022

Trial locations

Investigated drugs:

Ferric Carboxymaltose is a medication used in this clinical trial to treat patients who have recently experienced a heart attack and are suffering from iron deficiency. It is administered intravenously, meaning it is given directly into a vein. The purpose of using ferric carboxymaltose in this study is to see if it can reduce the risk of death and heart failure events, as well as improve the quality of life for these patients. The trial aims to evaluate how effective this treatment is compared to not receiving the medication.

Myocardial Infarction – This condition, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. It often results from a blockage in one or more of the coronary arteries due to a buildup of plaque. Symptoms can include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression can lead to complications such as heart failure or arrhythmias if not managed properly. Recovery and progression vary depending on the extent of the heart muscle damage and the individual’s overall health.

Trial ID:

2024-517206-28-00

Protocol code:

2019/ABM/01/00081

NCT ID:

NCT05759078

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Ferric Carboxymaltose on Heart Health and Quality of Life in Patients with Recent Heart Attack and Iron Deficiency

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?