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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

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
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Warsaw, Poland
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

14 criteria

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 trial?

1 criterion

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

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Verified sites

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Recruiting
Medicome Sp. z o.o.
Verified
Oświęcim, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

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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.

What is already known about the treatment

Ferric Carboxymaltose – This medication is administered intravenously and is currently being studied for its effects on patients who have recently experienced a heart attack and have iron deficiency. It is primarily used to improve iron levels in the body, which can help enhance the quality of life and reduce the risk of heart failure events. At the molecular level, ferric carboxymaltose works by replenishing iron stores, which is essential for the production of hemoglobin and the transport of oxygen in the blood. It is classified as an iron replacement therapy.

Investigated diseases

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.