RecruitingOBSERVATIONAL

MRI in Randomised Cohorts of Asymptomatic AS

This study is investigating if replacing a narrowed heart valve early, before symptoms appear, is better for people with severe aortic stenosis. Currently, treatment often waits until symptoms like chest pain or breathlessness develop. However, special heart scans (MRI) show that many people already have heart scarring by this point, which can affect their recovery. This research aims to compare early valve replacement with waiting for symptoms. Researchers will use MRI scans to see if early treatment leads to less scarring, better quality of life, and a smoother recovery. This will help doctors understand the best time to offer treatment for this common heart condition, potentially improving care for many people.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

230

Start

28 Jul 2021

Estimated completion

01 Sep 2031

Aortic Stenosis, Severe

What is this study about?

Heart valve problems are common, and one type is called aortic stenosis. This is when the main valve that lets blood leave your heart becomes stiff and narrow. Eventually, this makes your heart work harder to pump blood around your body. Current guidelines usually suggest waiting to replace this valve until you start having symptoms like chest pain, feeling breathless, or dizzy spells. However, we know from special heart scans, called MRI scans, that some people already have some scarring in their heart, even before they notice any symptoms. This scarring can make recovery after surgery more difficult.

This study is part of a bigger effort to understand if treating aortic stenosis earlier, before symptoms appear, could lead to better outcomes. The research will compare people who have their valve replaced early with those who wait until symptoms develop. By using MRI scans, the doctors want to see if early treatment can reduce the amount of scarring in the heart. They also want to understand if early treatment helps people have a better quality of life and a faster, more complete recovery after their valve is replaced.

Ultimately, the goal is to find out the best time to replace a narrowed aortic valve. The information from this study will help doctors make better decisions about when to offer treatment, potentially improving the health and well-being of many people with aortic stenosis. This means ensuring that people get the right treatment at the right time, rather than waiting too long.

Key takeaways

This study compares early heart valve replacement with waiting for symptoms.
It uses special heart scans (MRI) to check for heart scarring.
The goal is to see if earlier treatment leads to less scarring and better quality of life.
Results will help doctors decide the best time to treat aortic stenosis.
This study is for people already in the EASY AS or EVOLVED trials.

Who may be eligible?

To be able to join this study, you would need to be an adult, aged 18 or over. You must also already be taking part in one of two specific UK studies called EASY AS or EVOLVED. These are studies looking into early valve replacement for people who have severe aortic stenosis but don't yet have symptoms.

Crucially, you'd need to be happy to have one or two special heart scans called MRI scans. This is because the study relies on these scans to check for scaring in your heart. You'll also need to be able to understand the study information and agree to take part.

You would not be able to join if you have any medical conditions or implants that prevent you from having an MRI scan, such as certain pacemakers or severe claustrophobia (fear of enclosed spaces). Also, if your kidney function is very low, you wouldn't be able to participate.

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?
Are you currently taking part in the EASY AS or EVOLVED clinical trials?
Are you able and willing to have one or two MRI scans of your heart?
Do you have severe aortic stenosis but no noticeable symptoms yet?
Do you *not* have any medical reasons preventing an MRI scan (e.g., severe claustrophobia, certain metal implants)?
Is your kidney function not severely impaired?

Answer every question to see your result.

What does participation involve?

If you are invited and choose to take part in this study, you will have one or two special heart scans called MRI scans. The first scan will happen when you first join the study, and if you are in the group getting early valve replacement, a second scan will take place about three years later. These scans are used to look closely at your heart for any scarring.

In addition to the scans, you will be asked to fill out some questionnaires. These will help the researchers understand how the different treatment approaches affect your quality of life and your ability to carry out daily activities. You won't be given any new medications specifically for this study; it's about seeing the effects of the treatment strategy you're already assigned to in the main EASY AS or EVOLVED trials.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand the best time to treat aortic stenosis, potentially improving future care for many patients. You would also receive detailed MRI scans of your heart. As with any medical procedure, there are some potential risks associated with MRI scans, such as allergic reactions to the dye (if used) or discomfort if you are claustrophobic. If you have severe claustrophobia or certain medical implants, you would not be able to have an MRI. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Glenfield Hospital
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is 'aortic stenosis'?

It's a common heart problem where the main valve letting blood out of your heart becomes narrowed, making your heart work harder.

Why is this study important?

It's trying to find out if replacing the heart valve earlier, before symptoms appear, leads to better outcomes and less heart scarring.

What is an MRI scan?

It's a special type of scan that uses strong magnets and radio waves to create detailed pictures of your heart, helping doctors see inside.

Will I have a choice about my treatment?

No, your treatment (early valve replacement or watchful waiting) has already been decided if you are in the EASY AS or EVOLVED studies. This study observes the effects of that decision.

Will this study change my current medical care?

No, taking part in this study will not change the medical care you are already receiving for your aortic stenosis. It aims to gather more information.

How to find out more

Anvesha Singh, Dr

as707@leicester.ac.uk +44 116 252 3183 Official trial record

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