RecruitingOBSERVATIONAL

IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

This study, called IRONHEART, is investigating whether giving iron intravenously (through a drip) can help people with a specific type of heart failure and a common problem called iron deficiency. Heart failure makes your heart less effective at pumping blood, and iron deficiency can make symptoms worse. We want to see if this iron treatment improves heart function, how well people can exercise, and their general quality of life. Participants will have various tests like blood tests, heart scans, and walking tests before and after receiving the iron treatment to track any changes. This research is important because previous studies suggest iron given this way can be beneficial for heart failure patients.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

15 Apr 2024

Estimated completion

01 Feb 2027

Heart Failure Iron Deficiencies

What is this study about?

Heart failure is a condition where your heart isn't pumping blood as well as it should. This can make you feel tired and breathless. It's often linked with another common problem called iron deficiency, where your body doesn't have enough iron. This isn't just about feeling tired; iron deficiency can make heart failure symptoms worse and even increase health risks.

Previous research has shown that giving iron directly into a vein (intravenously) can improve the quality of life and how well people can exercise when they have heart failure and also have low iron levels. Because iron is so important for many body processes, including how our heart cells work, doctors want to understand more about how this treatment specifically affects heart function in people with heart failure that isn't caused by blockages in their heart arteries.

This study will involve a small group of people with this specific type of heart failure and iron deficiency. They will receive an iron treatment called ferric derisomaltose through a drip. The researchers will carefully observe whether this treatment leads to improvements in how the heart works, how much energy people have, and their overall well-being. The findings could help doctors better manage heart failure in the future.

Key takeaways

This study explores if intravenous iron helps a specific type of heart failure.
It aims to improve heart function and overall daily life.
Participation involves heart scans, blood tests, and walking tests.
All participants will receive the iron treatment (ferric derisomaltose).
Participation lasts slightly over one month with follow-up appointments.
It is for adults with non-ischaemic heart failure and iron deficiency.

Who may be eligible?

To join this study, participants need to be adults aged 18 or over who have been diagnosed with a specific type of heart failure where their heart's pumping ability is reduced. This heart failure should not be caused by blocked heart arteries. You also need to have iron deficiency, which will be checked with a blood test. Importantly, you should already be on specific heart failure medications, including a type called SGLT2 inhibitors, for at least four weeks, and your heart failure symptoms should fall within a certain range.

There are several reasons why someone might not be able to join. For example, if your heart failure is caused by blocked arteries, or if you have severe kidney problems requiring dialysis. Other conditions like certain heart rhythm problems (atrial fibrillation), active cancer, or moderate to severe heart valve issues would also prevent participation. If you've recently had a heart attack, certain heart procedures, or have complex heart defects from birth, you wouldn't be eligible. Also, pregnant individuals or those with certain implanted heart devices or who have had heart or other organ transplants cannot take part.

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?
Do you have heart failure NOT caused by blocked heart arteries?
Have you been told you have iron deficiency?
Are you currently taking specific heart failure medications, including SGLT2 inhibitors?
Do you NOT have severe kidney disease or require dialysis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have several checks to make sure the study is right for you. These will include blood tests, a heart scan (called a cardiac MRI), a walking test to see how far you can walk in six minutes, and a test of your hand grip strength. You'll also fill out a questionnaire about your quality of life.

Then, you will receive the iron treatment, ferric derisomaltose, through a drip. This is given as standard care. You'll have follow-up checks very similar to the initial ones. The first follow-up will be about 24 hours after you receive the iron, and the second will be 30 days later. These checks help the researchers see if the treatment has made any changes to your heart function or how you feel. The total duration of active participation, including all tests and the iron infusion, will be just over one month.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that receiving intravenous iron might improve your heart function, exercise ability, and overall well-being, as suggested by previous research. However, this is not guaranteed, and the treatment might not help everyone. Potential risks of receiving intravenous iron can include allergic reactions, headaches, dizziness, or temporary changes in blood pressure. There's also the discomfort of blood tests and the MRI scan. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should, which can cause symptoms like tiredness and breathlessness.

What is iron deficiency?

Iron deficiency means your body doesn't have enough iron, which is important for your energy and overall health. It's common in people with heart failure.

What is 'intravenous iron'?

Intravenous iron means iron that is given directly into your bloodstream through a drip, rather than taken as a tablet.

What is a cardiac MRI?

A cardiac MRI is a special scan that uses magnets and radio waves to create detailed pictures of your heart, helping doctors see how well it's working.

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

This study gives all participants the active iron treatment; there is no placebo group.

How to find out more

Flett

andrew.flett@uhs.nhs.uk +442381205906 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.