RecruitingOBSERVATIONAL

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

This study focuses on people with an irregular heartbeat, called atrial fibrillation, who also have problems with their heart valves (mitral and tricuspid regurgitation). These valve issues mean blood leaks backwards, which can affect the heart's function. The research aims to understand these valve conditions better, including what causes them, how they progress, and how they affect patients over time. By looking at different types of valve problems, the study hopes to improve how doctors understand and care for people living with these heart conditions in the future.

At a glance

Status

Recruiting

Sponsor

Barts & The London NHS Trust

Enrolment target

141

Start

23 Aug 2023

Estimated completion

01 Aug 2027

Atrial Fibrillation Functional Mitral Regurgitation Functional Tricuspid Regurgitation

What is this study about?

This research study is looking into specific heart valve problems that can happen to people who have an irregular heartbeat, known as atrial fibrillation. Our hearts have four valves that act like one-way doors, making sure blood flows in the right direction. Sometimes, these valves don't close properly, causing blood to leak backwards. This is called 'regurgitation'.

In this study, we're focusing on two particular valves: the mitral valve and the tricuspid valve. When these valves leak because of atrial fibrillation, it's called 'functional mitral regurgitation' or 'functional tricuspid regurgitation'. Doctors don't fully understand why these problems happen in some people with atrial fibrillation, or how they might develop over time. This study aims to fill those gaps in our knowledge.

By carefully observing people with these conditions, the researchers hope to identify different patterns of disease and find out what factors might lead to the condition getting worse. The goal is to better understand these heart valve problems so that, in the future, doctors can provide better care and treatment for people affected by them.

Key takeaways

This study aims to understand heart valve issues in people with an irregular heartbeat.
It focuses on 'leaky' heart valves (mitral and tricuspid regurgitation) linked to atrial fibrillation.
Participation involves heart scans (echocardiograms) and a blood test over about a year.
No new treatments are given; it's about gathering information to help future patients.
You can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with an irregular heartbeat called atrial fibrillation. You also need to have been told by your doctor that you have a moderate or severe problem with your heart's mitral or tricuspid valve that is functional (meaning it's related to your atrial fibrillation, not a problem with the valve itself).

It's important that we can get clear scan images of your heart to participate. Unfortunately, you usually wouldn't be able to join if you have a different type of heart valve problem (not caused by atrial fibrillation) or if your heart's main pumping chamber (the left ventricle) isn't working strongly enough. You also need to be willing and able to understand the study and agree to 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 atrial fibrillation (an irregular heartbeat)?
Have you been told you have moderate or severe 'functional' mitral or tricuspid valve regurgitation?
Can you provide clear heart scan images?
Is your main heart pumping chamber working well (not significantly weakened)?
Do you *not* have a different type of heart valve problem (e.g., a genetic valve issue)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here’s what you can expect:

* **Initial Visit:** You will have a detailed heart ultrasound scan, called an echocardiogram, to get a clear picture of your heart valves. You will also have a special fitness test with an echocardiogram (a 'Cpex Echocardiography') and a blood test to measure something called BNP, which helps doctors assess your heart health. * **Follow-up:** Approximately one year after your initial visit, you will come back for another heart ultrasound scan (echocardiogram) to see if there have been any changes in your heart valves. * **Duration:** Your active participation in the study involves these assessments over roughly a one-year period. There are no study medications involved.

All appointments will likely take place at St Bartholomew's Hospital.

Potential risks and benefits

Taking part in this study could help doctors learn more about heart valve problems linked to atrial fibrillation, which might benefit future patients. The procedures involved, like echocardiograms and blood tests, are generally safe with very low risks, though you might feel a slight pinch during the blood test or some discomfort during the fitness test. You are free to stop participating in 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.

St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'atrial fibrillation'?

It's a type of irregular and often very rapid heartbeat that can cause symptoms like breathlessness or tiredness.

What does 'functional mitral or tricuspid regurgitation' mean?

It means one of your heart valves isn't closing properly, letting blood leak backward, but the valve itself isn't damaged. The leak is 'functional', often due to how your heart is working with atrial fibrillation.

What is an echocardiogram?

It's a type of ultrasound scan that uses sound waves to create moving pictures of your heart, showing how your blood flows and how your heart valves are working.

Will I get any treatment in this study?

No, this is an observational study, meaning researchers are just gathering information. You won't receive any new treatments through the study.

Where will the study take place?

The study assessments will take place at St Bartholomew's Hospital.

How to find out more

Jawza Aldakhil

jawza@outlook.sa 00447899770693 Official trial record

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