Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI

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What is this study about?

This clinical trial is focused on studying the effects of an iron infusion treatment in elderly patients who have a condition called Aortic Stenosis and are also experiencing Iron Deficiency. Aortic stenosis is a heart condition where the valve that controls blood flow from the heart to the rest of the body becomes narrowed, making it difficult for the heart to pump blood. Iron deficiency occurs when the body does not have enough iron, which is essential for producing healthy red blood cells. The treatment being tested in this study is called Ferinject, which contains a substance known as Ferric Carboxymaltose. This is a type of iron given through an injection or infusion directly into the bloodstream.

The purpose of the study is to determine if this iron treatment can improve the quality of life and exercise capacity in patients who are undergoing a procedure called Transcatheter Aortic Valve Implantation (TAVI). TAVI is a minimally invasive procedure used to replace the narrowed aortic valve. Participants in the study will receive either the iron treatment or a placebo. Over the course of the study, participants will be monitored for changes in their quality of life, ability to exercise, and cognitive function, which refers to mental processes like thinking and memory.

The study will last for several months, during which participants will undergo various assessments, including questionnaires and a walking test, to evaluate their progress. The main goal is to see if the iron treatment can help improve the overall well-being and physical abilities of those with severe aortic stenosis and iron deficiency. The results will help determine if this treatment could be beneficial for similar patients in the future.

1 joining the study

Participation begins after signing an informed consent form, confirming understanding and agreement to the trial’s procedures and objectives.

Eligibility is confirmed based on criteria such as age (65 years or older), presence of severe aortic stenosis, and iron deficiency.

2 initial assessments

Initial assessments include evaluating quality of life, exercise capacity, and cognitive function.

Quality of life is assessed using a questionnaire, exercise capacity is measured with a 6-minute walk test, and cognitive function is evaluated through a questionnaire.

3 treatment administration

The treatment involves receiving an intravenous iron infusion using ferric carboxymaltose, known as Ferinject.

The infusion is administered parenterally, meaning it is given by injection or infusion directly into the bloodstream.

4 follow-up assessments

Follow-up assessments occur at 6 months to evaluate the primary and secondary endpoints.

Primary endpoints include quality of life and exercise capacity, while secondary endpoints assess cognitive function, NYHA classification, patient global assessment, and other health outcomes.

5 completion of the trial

The trial is estimated to end by December 31, 2028.

Final assessments and data collection are completed to evaluate the overall impact of the treatment on quality of life and health outcomes.

Who Can Join the Study?

Patient must be 65 years or older.
Patient must have severe aortic stenosis and iron deficiency and be undergoing a successful TAVI procedure. Aortic stenosis is a condition where the heart’s aortic valve narrows. Iron deficiency means having low levels of iron in the body.
Iron deficiency is defined as having ferritin levels less than 100 micrograms per liter (ug/L) or transferrin saturation less than 20%. Ferritin is a protein that stores iron, and transferrin saturation is a measure of how much iron is bound to a protein that carries iron in the blood.
Patient must be able to complete assessments for quality of life, exercise capacity, and cognitive function. This includes filling out questionnaires and performing a 6-minute walk test, which measures how far you can walk in six minutes.
Patient must have signed an Informed Consent form, which means they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who do not have severe Aortic Stenosis and Iron Deficiency cannot participate. Aortic Stenosis is a condition where the heart’s aortic valve narrows, and Iron Deficiency means having low levels of iron in the body.
Patients who are not undergoing TAVI cannot participate. TAVI stands for Transcatheter Aortic Valve Implantation, a procedure to replace the aortic valve.
Patients who are outside the specified age range cannot participate. The study includes certain age groups only.
Patients who belong to a vulnerable population are not eligible. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ezeeyod Untsixgwhkxb Mhyovyf Caysokf Reypinpot (rlxtoer Mok	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	15.01.2024

Trial locations

Investigated drugs:

Ferric Carboxymaltose

Ferric Carboxymaltose is an intravenous iron treatment used in this trial. It is given to patients who have severe aortic stenosis and iron deficiency. The goal of using this medication is to improve the quality of life and exercise capacity in these patients who are undergoing a procedure called Transcatheter Aortic Valve Implantation (TAVI).

Investigated diseases:

Aortic Stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. This narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken over time. Symptoms may include chest pain, fatigue, shortness of breath, and fainting, especially during physical activity. As the condition progresses, it can lead to heart failure if the heart cannot pump enough blood to meet the body’s needs. The severity of symptoms often correlates with the degree of valve narrowing.

Iron Deficiency – Iron deficiency occurs when the body lacks enough iron to produce adequate levels of hemoglobin, the protein in red blood cells that carries oxygen. This deficiency can lead to anemia, characterized by fatigue, weakness, pale skin, and shortness of breath. Iron deficiency can result from inadequate dietary intake, increased iron needs, or loss of iron through bleeding. Over time, the lack of iron can impair physical and cognitive performance and weaken the immune system. It is a common nutritional deficiency worldwide, affecting various age groups.

Trial ID:

2023-505095-29-03

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?