Not yet recruitingOBSERVATIONAL

Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)

This study explores how your body's immune system copes with the stress of open-heart surgery to replace an aortic valve. We know that heart surgery can be tough on the body, but it's not clear how individual immune systems respond. Researchers want to see if measuring how well someone's immune system is working, both before and during surgery, can predict how they will recover afterwards. This could include how quickly they heal and if they get infections. By understanding this better, doctors hope to find new ways to help patients have a safer and smoother recovery after their heart operation.

At a glance

Status

Not yet recruiting

Sponsor

Barts & The London NHS Trust

Enrolment target

150

Start

01 Sep 2025

Estimated completion

01 Sep 2026

Aortic Valve Disease Surgery--Complications Immune System Disorder

What is this study about?

When you have heart surgery, especially to replace a valve, your body goes through a lot. Your immune system, which is your body's natural defence against illness and infection, has to work hard to help you recover. This study aims to understand exactly how your immune system reacts during and after this type of surgery.

The researchers want to see if there's a link between how well your immune system responds and how you recover. For example, if your immune system is particularly strong, does it mean you'll have fewer infections or leave the hospital sooner? They will also look at new, faster ways to measure your immune system's activity. The goal is to discover if these measurements can predict who might have a trickier recovery and who might bounce back more easily.

Ultimately, if they find clear links, it could lead to better ways of supporting people before, during, and after heart surgery. This might involve giving you specific information about your risks, boosting your immune system through things like special nutrition, or even considering different types of procedures that might be less stressful on your body.

Key takeaways

Study explores how immune system reacts to heart valve surgery.
Aims to predict recovery based on immune response.
Could lead to better care for heart surgery patients.
Involves blood samples taken during existing medical procedures.
No extra hospital visits or additional needles.
Participation is voluntary and can be withdrawn at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and be about to have your first open-heart surgery to replace an aortic valve. This particular type of surgery is when the chest is opened to replace the heart valve.

There are some reasons why you wouldn't be able to take part. For example, if you're currently fighting a serious infection, or if you're taking medicines that weaken your immune system. Also, if you already have a condition that affects your immune system, or if you are pregnant, this study wouldn't be suitable for you.

Quick self-check

Are you 18 years old or older?
Are you having open-heart surgery for the first time to replace your aortic valve?
Are you currently free from any serious infections?
Are you NOT taking medicines that weaken your immune system?
Do you NOT have a known condition that affects your immune system?
Are you NOT pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first meet with the study team at the hospital's pre-assessment clinic. They will explain everything in detail and answer any questions you have. If you agree, you'll sign a consent form.

During your surgery, when you're already asleep under anaesthetic, a small amount of blood (about 4 teaspoons) will be taken. This will happen again at the end of your surgery, 24 hours later, when you're ready to leave the hospital, and finally at a follow-up appointment about four weeks after your operation. These blood samples will be taken using needles that are already being used for your routine care, so you won't have any extra needle pokes just for the study. The study team will also collect general information about your recovery, like how long you stay in hospital. This will continue for up to one year after your surgery, using information that is already routinely collected as part of your care.

Potential risks and benefits

Taking part in this study won't directly benefit your health immediately, but the information gained could be very helpful for future patients having similar heart surgery by finding ways to improve their recovery. The main risk is the small discomfort of the blood tests, though these will be done at the same time as your routine blood draws, so there won't be any additional needles. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

St Bartholomew's Hospital
London, United Kingdom

Common questions

What is an 'aortic valve replacement'?

It's a type of open-heart surgery where a damaged valve in your heart (the aortic valve) is replaced with a new one.

Will taking part involve extra hospital visits?

No, all study-related activities will happen during your existing hospital appointments and surgery.

What will happen to my blood samples?

They will be analysed in a lab to understand how your immune system responds to surgery.

Will I find out my results from the study?

The study aims to understand general patterns. Individual results aren't typically shared back with participants.

What if I change my mind about participating?

You can withdraw from the study at any time without a reason, and it won't affect your medical care.

How to find out more

Colin Hamilton-Davies, MBBS MD

colin.hamilton-davies@qmul.ac.uk +44(0)2037658348 Official trial record

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