RecruitingOBSERVATIONAL

Exercise CMR in (p)LF-LG AS

This research is for people diagnosed with severe aortic stenosis, a condition where one of the heart's main valves doesn't open properly. We're interested in those with a specific type called low-flow low-gradient aortic stenosis. The study involves having a special heart MRI scan (CMR) while doing light exercise. This is done in addition to the usual checks you would have before a procedure called TAVR, which replaces the faulty heart valve. By observing how your heart responds during exercise with these detailed scans, doctors hope to get a clearer picture of your condition and make sure you receive the most suitable treatment.

At a glance

Status

Recruiting

Sponsor

University of Göttingen

Enrolment target

100

Start

01 Nov 2023

Estimated completion

31 Dec 2026

Aortic Stenosis, Severe

What is this study about?

This study is about a heart condition called severe aortic stenosis. This happens when the aortic valve, which controls blood flow out of your heart, becomes stiff and narrow. This makes your heart work much harder. We're specifically focusing on a type of severe aortic stenosis where the blood flow through the valve is reduced, which doctors call 'low-flow low-gradient'.

Before you have a procedure called TAVR (Transcatheter Aortic Valve Replacement), which replaces the faulty valve, doctors usually do a lot of tests to understand your heart condition. This study adds a special kind of detailed heart scan, called a Cardiac Magnetic Resonance (CMR) scan, to these routine checks. What's different is that we'll be doing this scan while you're doing some gentle exercise.

The main idea is to see how your heart functions and adapts when it's under a little bit of stress during exercise. By getting this detailed view of your heart's response, doctors hope to gain a much better understanding of your specific condition. This information can then help them decide on the best course of treatment for you, making sure your care is as effective as possible.

Key takeaways

This study is for people with severe aortic stenosis.
It uses a special exercise MRI scan of the heart.
The scan helps doctors understand your heart's function better.
The goal is to improve treatment decisions for you.
Participation involves one additional specialist scan.
You can always choose to withdraw from the study.

Who may be eligible?

This study is looking for adults who have been diagnosed with a severe aortic valve problem where the blood flow through the valve is reduced. This specific diagnosis is known as 'paradoxical' or 'conventional low-flow low-gradient aortic stenosis' by your doctor.

There are also some reasons why you might not be able to join. For example, if you have a medical device in your body that isn't safe for an MRI scan, or if you can't lie flat and still for about 40 minutes, perhaps due to claustrophobia (fear of small spaces). If you have severe kidney problems (with an eGFR below 30), or if you are allergic to the special dye used in some MRI scans, you also wouldn't be able to take part.

Finally, if you find it difficult to do light exercise while lying down, then this study might not be suitable for you.

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.

Do I have severe aortic stenosis where blood flow through the valve is reduced?
Do I have a medical device that's safe for an MRI scan?
Can I lie flat and still for about 40 minutes?
Do I have kidney problems (eGFR below 30)? (If yes, you may not be able to join)
Am I allergic to MRI contrast dye?
Can I do light leg exercise while lying down?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have an extra heart scan called a Cardiac Magnetic Resonance (CMR) scan. This scan will be done while you are doing some gentle exercise, all while lying down. This is in addition to the standard tests your doctor would normally recommend before a procedure to replace your heart valve. The entire scan itself is expected to last about 40 minutes. You won't be given any new medications specifically for this study. The total duration of your participation will involve these additional tests before your planned valve replacement procedure.

Potential risks and benefits

Taking part might help us learn more about your heart condition, which could lead to better ways to decide on treatments in the future. You might also gain a clearer understanding of your own heart health. However, there are some potential risks. These include the usual risks associated with an MRI scan, such as being in a confined space. There's also the slight risk linked to the physical activity and the contrast dye used during the scan, though these are generally considered safe. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (1)

University Hospital Goettingen
Verified postcode
Göttingen, Germany· Recruiting

Common questions

What is severe aortic stenosis?

It's a heart condition where a main valve in your heart called the aortic valve becomes narrow and stiff, making it harder for blood to flow out of your heart.

What is a CMR scan?

CMR stands for Cardiac Magnetic Resonance. It's a special type of MRI scan that takes very detailed pictures of your heart and blood vessels.

Why is the scan done during exercise?

By scanning your heart while it's working a bit harder, doctors can see how it responds under stress, which provides more information than scans done at rest.

Will I need to take new medicines for this study?

No, you will not be given any new medications as part of this study. You will continue any medicines you are already prescribed by your doctor.

How long will the scan take?

The exercise CMR scan is expected to last for about 40 minutes.

How to find out more

Official trial record

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