RecruitingOBSERVATIONAL

Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients

This study aims to discover if a new type of heart scan, called native T1 mapping, can accurately measure scarring in the hearts of people who have advanced kidney disease and are on dialysis. Currently, it's hard to properly check for this scarring, but this new MRI technique might be a good solution. Researchers need to compare the results of this scan directly with actual heart scarring to make sure it's accurate and reliable. If successful, this gentle, non-invasive scan could help doctors understand and monitor heart health better in dialysis patients, potentially leading to improved care and treatments in the future.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

03 Nov 2019

Estimated completion

31 Dec 2025

End Stage Kidney Disease Fibrosis Myocardial

What is this study about?

When people have advanced kidney disease and are on dialysis, their hearts can sometimes develop scarring, which is not good for their health. Currently, doctors don't have a good way to measure this scarring accurately and easily.

This study is looking at a new type of heart scan, called native T1 mapping. It's a special kind of MRI scan that doesn't use dyes or injections, which is a good thing! This scan works by looking at the water content in your heart tissue to understand its health. Previous research has hinted that this scan could be really useful for seeing heart scarring in people with kidney problems.

The main goal of this study is to check how accurate this new scan really is. To do this, researchers need to compare the scan results directly with what's actually happening inside the heart. This is a very important step to make sure the scan is reliable before it can be used more widely to help patients in the future.

Key takeaways

Exploring a new, dye-free MRI scan for heart scarring in dialysis patients.
Aims to validate the accuracy of this new scan against actual heart tissue.
Could lead to better ways of monitoring heart health in people on dialysis.
Participation involves an MRI, echocardiogram, heart monitor, blood tests, and post-mortem heart examination.
Individuals must be on haemodialysis and on supportive care register (expected death within 12 months).

Who may be eligible?

This study is looking for people who are currently on haemodialysis, which means they've been having dialysis for at least three months. Importantly, participants should be on a 'supportive care register,' meaning their doctors expect them to pass away within the next 12 months.

To join, you need to be able to understand information about the study both by reading and listening, and be able to decide for yourself if you want to take part. You also need to agree that your heart can be used for research after you pass away.

You won't be able to take part if you have things that stop you from having an MRI scan, like a pacemaker or certain metal implants in your body, or if you get very anxious in enclosed spaces (claustrophobia). People with certain heart conditions that might be related to other diseases (like amyloidosis) also cannot join. And, of course, if you can't understand the information or give your consent, you won'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 currently undergoing haemodialysis treatment and have you been for at least 3 months?
Are you on the supportive care register with an anticipated lifespan of less than 12 months?
Can you understand written and spoken English explanations easily?
Are you able to agree to donate your heart for research after you pass away?
Do you have any medical devices like a pacemaker that might prevent you from having an MRI scan?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would have an MRI scan of your heart to use this new T1 mapping technique. You would also have an echocardiogram, which is another type of heart scan that uses sound waves. We would also take some blood samples. For two days (48 hours), you would wear a small device that continuously monitors your heart's activity. The study would then look at your heart after your passing (cardiac explantation) to compare the scan results with the actual condition of your heart tissue. There isn't a fixed total duration for the study participation as it depends on individual circumstances.

Potential risks and benefits

The potential benefits of taking part include helping researchers better understand and measure heart scarring in dialysis patients, which could lead to improved care for others in the future. Risks include those generally associated with MRI scans (though this one is non-contrast), blood tests, and wearing a heart monitor. The study also involves a post-mortem examination of the heart, which some may find sensitive. Remember, you can choose to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is 'haemodialysis'?

Haemodialysis is a medical treatment that filters waste and excess water from your blood when your kidneys are not working properly.

What is 'heart scarring'?

Heart scarring, also called fibrosis, is when healthy heart muscle is replaced by stiff, non-working tissue. This can make it harder for your heart to pump blood effectively.

What is a 'native T1 mapping MRI'?

It's a special type of heart MRI scan that doesn't use any injected dye. It looks at the natural properties of your heart tissue to detect changes like scarring.

Will this study directly help my health?

While this study might not directly improve your health immediately, the information gathered is crucial for developing better ways to understand and treat heart problems in dialysis patients in the future.

What does giving 'informed consent' mean?

It means you fully understand what the study involves, its potential risks and benefits, and you freely agree to take part without feeling pressured.

How to find out more

James Burton, DM, FRCP

jb343@le.ac.uk +44 (0)116 2588043 Official trial record

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