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A Study of Intravenous Ferric Carboxymaltose on Quality of Life in Older Adults with Acute Coronary Syndrome and Iron Deficiency

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What is this trial about?

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

This study is looking at Acute Coronary Syndrome, which is a serious heart condition that happens when blood flow to the heart muscle is suddenly reduced or blocked. The treatment being studied is Ferinject, which contains ferric carboxymaltose, a form of iron that is given directly into a vein. Iron deficiency is a condition where the body does not have enough iron, which is an important mineral needed for many body functions. In this study, some patients will receive intravenous iron treatment while others will not receive this treatment, allowing researchers to compare the effects between the two groups.

The purpose of this study is to find out whether older patients who are 65 years or older with iron deficiency after experiencing an acute coronary syndrome have a better quality of life when they receive intravenous iron treatment compared to those who do not receive it. Quality of life refers to a person's overall wellbeing and how they feel in their daily activities. The study will look at quality of life changes after 6 months and 12 months of follow-up.

Patients who take part in this study will be randomly assigned to either receive the intravenous iron treatment or not receive it. The study will follow patients for 12 months and will measure various health outcomes including changes in quality of life scores, changes in frailty levels, and the occurrence of heart-related problems such as heart failure requiring hospital admission, heart attack, or stroke. The study will also look at markers in the blood related to iron levels, inflammation, and aging in some patients. Researchers will track how patients are doing throughout the year to see if the iron treatment makes a difference in their health and wellbeing.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and randomization
After joining the study, your baseline health status will be assessed. This includes measurements of your quality of life using a questionnaire called EQ-5D-5L, which evaluates your mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Your frailty will be assessed using the FRAIL Scale, which measures your physical strength and endurance.
Blood samples will be taken to measure inflammatory markers such as CRP (a protein that increases when there is inflammation in your body) and hs-CRP (a more sensitive measurement of the same protein).
In a subgroup of participants, additional blood samples will be collected to measure iron metabolism markers (substances that show how your body processes iron), inflammatory markers (substances that indicate inflammation), biological age markers (indicators of how your body is aging), and telomere length (a measure related to cell aging).
You will be randomly assigned to one of two groups: one group will receive intravenous iron treatment (iron given directly into a vein), and the other group will not receive this treatment.
Step 2
Treatment phase
If you are assigned to the treatment group, you will receive ferric carboxymaltose (the active substance in Ferinject), which is a form of iron given through an intravenous injection or infusion (directly into your vein).
The specific dosage, frequency, and duration of the iron administration will be determined based on your individual iron deficiency levels and clinical needs.
If you are assigned to the control group, you will not receive intravenous iron treatment but will continue with standard care for your condition.
Step 3
Six-month follow-up assessment
At 6 months after starting the study, your quality of life will be reassessed using the same EQ-5D-5L questionnaire to measure any changes compared to the initial assessment.
Your frailty will be evaluated again using the FRAIL Scale to determine if there have been any changes in your physical condition.
Step 4
Twelve-month follow-up assessment
At 12 months after starting the study, your quality of life will be assessed once more using the EQ-5D-5L questionnaire.
Your frailty will be measured again with the FRAIL Scale.
Blood samples will be taken to measure changes in CRP and hs-CRP levels compared to the beginning of the study.
In the subgroup, additional blood samples will be collected to measure changes in iron metabolism markers, inflammatory markers, biological age markers, and telomere length compared to baseline values.
Throughout the entire 12-month period, any occurrences of heart failure requiring hospitalization (when your heart cannot pump blood effectively and you need hospital care), non-fatal heart attack (a heart attack that does not result in death), stroke (when blood flow to part of your brain is blocked), or death from any cause will be recorded.

Who can join the trial?

4 criteria

You must be 65 years old or older.
You must have been diagnosed with acute coronary syndrome, which is a serious heart condition that happens when blood flow to the heart muscle is suddenly reduced or blocked. This diagnosis must have been made within the last 15 days.
You must have iron deficiency, which means your body does not have enough iron. This must have been confirmed either when you were admitted to the hospital or within 15 days after your heart event. The iron deficiency must not have been treated yet. Iron deficiency is confirmed by blood tests showing either: your serum ferritin (a protein that stores iron in your body) is less than 100 ng/mL, or your transferrin saturation (a measure of how much iron is being carried in your blood) is less than 20%.
You must be able to understand the details of the study and be willing to sign a written informed consent form before any study procedures begin. This means you agree to participate after learning about what the study involves.

Who cannot join the trial?

1 criterion

No specific exclusion criteria have been provided for this clinical trial in the available information.

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Verified sites

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Clinico San Carlos
Madrid, Spain
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Hospital Universitario De Leon
Leon, Spain

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Investigated drugs

Intravenous iron is a medication given through a vein to treat iron deficiency. Iron is an important mineral that your body needs to make red blood cells and carry oxygen throughout your body. When you don't have enough iron, you may feel tired and weak. This treatment helps restore your iron levels and may improve your energy and overall quality of life.

Ferric Carboxymaltose

What is already known about the treatment

Intravenous Iron – Intravenous iron is a medication given directly into the bloodstream through a vein to treat iron deficiency, which is a condition where the body doesn't have enough iron to produce healthy red blood cells. This treatment is being studied in elderly patients who have experienced acute coronary syndrome (a serious heart condition) to see if correcting their iron levels can improve their overall quality of life and physical functioning. The iron works by replenishing the body's iron stores, which helps restore normal production of hemoglobin, the protein in red blood cells that carries oxygen throughout the body. This medication is currently approved and used in medical practice for treating iron deficiency, particularly in patients who cannot take oral iron supplements or need rapid iron replacement.

Investigated diseases

Acute Coronary Syndrome
Acute coronary syndrome is a condition that occurs when blood flow to the heart muscle is suddenly reduced or blocked. This happens due to the buildup of fatty deposits in the coronary arteries or when a blood clot forms in these arteries. The reduced blood flow means the heart muscle does not receive enough oxygen, which can damage the heart tissue. Patients typically experience chest pain or discomfort, which may spread to the arms, neck, jaw, or back. Other symptoms can include shortness of breath, sweating, nausea, and feeling lightheaded. The condition requires immediate medical attention as the lack of oxygen can cause permanent damage to the heart muscle.
Iron Deficiency
Iron deficiency is a condition where the body does not have enough iron to produce adequate amounts of healthy red blood cells. Iron is essential for making hemoglobin, the protein in red blood cells that carries oxygen throughout the body. When iron levels are low, the body cannot produce enough hemoglobin, leading to reduced oxygen delivery to tissues and organs. Common symptoms include tiredness, weakness, pale skin, and difficulty concentrating. People may also experience shortness of breath, dizziness, cold hands and feet, and brittle nails. The condition can develop gradually over time as the body's iron stores become depleted.
Heart Failure
Heart failure is a condition where the heart is unable to pump blood effectively enough to meet the body's needs. The heart muscle may become too weak or too stiff to fill with blood and pump it out properly. This causes blood to back up in the veins and fluid to accumulate in the lungs and other tissues. Common symptoms include shortness of breath, especially during physical activity or when lying down, persistent fatigue, and swelling in the legs, ankles, and feet. Patients may also experience rapid or irregular heartbeat, reduced ability to exercise, and persistent cough or wheezing. The condition typically develops gradually as the heart tries to compensate for its reduced pumping ability.