AuthorisedTherapeutic use (Phase IV)Interventional

Iron Infusion in Elderly Patients undergoing Transcatheter Aortic Valve Implantation (IRON TAVI) Trial

This study is called the IRON TAVI trial. It focuses on older patients who have a condition called aortic stenosis, where a main heart valve doesn't open properly, and also have low iron levels. These patients are undergoing a procedure called Transcatheter Aortic Valve Implantation (TAVI) to fix their heart valve. The trial is investigating whether giving these patients an iron infusion, specifically a medicine called Ferinject, can improve their quality of life and their ability to exercise six months after their TAVI procedure. Researchers will use questionnaires and walking tests to measure these improvements.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

378

Start

07 Dec 2023

Patients with Aortic stenosis and Iron deficiency

What is this study about?

This study is looking into a treatment for older patients who have two health issues at once: a heart problem called aortic stenosis and low iron levels. Aortic stenosis means that one of the main valves in your heart, the aortic valve, has become stiff and narrowed, making it harder for your heart to pump blood around your body. This can make you feel tired or breathless.

These patients are having a procedure called Transcatheter Aortic Valve Implantation, or TAVI. This procedure replaces the faulty heart valve without the need for open-heart surgery, which is often a good option for older or frailer patients. The study wants to find out if giving an iron infusion (a treatment to boost iron levels) called Ferinject, after their TAVI procedure, can help them feel better.

The main aim is to see if this iron treatment improves their overall quality of life and how well they can do daily activities, like walking, six months after their valve procedure. Researchers will collect information on their general well-being, memory, and hospital visits related to their heart condition to get a full picture of the treatment's effects. It's hoped that by treating low iron, patients will recover better and enjoy an improved quality of life.

Key takeaways

This study is for older patients with a heart valve problem and low iron.
It tests if an iron infusion, Ferinject, helps after a TAVI heart procedure.
Researchers will check quality of life and exercise ability over six months.
The aim is to see if iron treatment improves recovery and well-being.
Patients aged 18 and over, with aortic stenosis and iron deficiency, undergoing TAVI, may be eligible.

Who may be eligible?

This study is open to both men and women, aged 18 years and above, with no upper age limit.

To be considered for the study, you would need to have been diagnosed with aortic stenosis (a problem with one of your heart valves) and to be undergoing a procedure called TAVI (Transcatheter Aortic Valve Implantation) to replace that valve. You would also need to have been diagnosed with iron deficiency, meaning you have low iron levels in your blood.

Your medical team would be able to confirm if you meet all the specific requirements to take part in this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with aortic stenosis (a heart valve problem)?
Are you scheduled to have a TAVI procedure (heart valve replacement)?
Do you have low iron levels (iron deficiency)?
Are you willing to have an iron infusion (Ferinject)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive an iron infusion called Ferinject. Over the six months following your TAVI procedure, you will have several assessments. These will include filling out questionnaires about your quality of life, how you feel generally, and your memory. You'll also do walking tests to see how far you can walk in six minutes, which helps to measure your exercise capacity. The study will also track any hospital visits or major health events during this period. The full duration of your active participation, including follow-up, will be six months.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as an improved quality of life and better exercise ability due to the iron infusion, although this is what the study is trying to confirm. As with any medical treatment, there's always a possibility of minor side effects from the iron infusion, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is TAVI?

TAVI is a procedure to replace a faulty heart valve without open-heart surgery, often used for older patients.

What does 'iron deficiency' mean?

It means you have low levels of iron in your blood, which can make you feel tired and weak.

What is Ferinject?

Ferinject is a medicine given as an infusion (into your vein) to quickly boost your iron levels.

How long does the study last for each patient?

Each patient will be part of the study for six months after their TAVI procedure.

Will I know if I'm getting the iron treatment?

This study focuses on patients who are already receiving the iron treatment, so participants will know they are getting the iron infusion.