Active not recruitingOBSERVATIONAL

Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD

This study is investigating a new 3D ultrasound technique to measure how well the right side of the heart is pumping. It's for adults who previously had surgery for a heart condition called Tetralogy of Fallot and now have moderate to severe 'leaky heart valve' (pulmonary regurgitation). The main goal is to see if this new 3D ultrasound is as accurate as MRI scans, which are currently the best method, and if it's better than older ultrasound tests. Researchers will also compare the heart measurements of these patients with healthy adults. They hope this new method could help doctors decide the best time for further treatment, ensuring patients get the right care at the right moment.

At a glance

Status

Active not recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

11 Apr 2024

Estimated completion

26 Sep 2025

Tetralogy of Fallot

What is this study about?

This study is for adults who have a heart condition called Tetralogy of Fallot (ToF) and had surgery for it when they were younger. ToF is a complex heart problem that affects how the right side of the heart works. After the initial surgery, some adults develop what's known as 'pulmonary regurgitation,' which means a valve in their heart (the pulmonary valve) is leaky. This can cause the right side of the heart to work harder and become enlarged over time, sometimes needing further surgery.

Currently, the best way to accurately measure the size and pumping ability of the right side of the heart is using an MRI scan. However, MRI isn't always the first test doctors use in everyday practice. This study wants to find out if a new 3D ultrasound method (called TTE-3DKBR) can give equally good and reliable measurements of the right side of the heart. If it can, this new ultrasound could be a more convenient and widely available tool for doctors.

The researchers will compare the results of this new 3D ultrasound with MRI scans in adults with ToF. They will also compare it to standard 2D ultrasound tests that doctors usually perform. Additionally, the study will involve a group of healthy adult volunteers to ensure the new method works well for everyone. By seeing how accurate and consistent this new 3D ultrasound is, the study aims to help doctors make better decisions about when follow-up treatments, like replacing a leaky valve, might be needed.

Key takeaways

This study aims to find a simpler, highly accurate way to check heart health in adults with Tetralogy of Fallot.
It uses a new 3D ultrasound compared to MRI and standard ultrasound tests.
'Pulmonary regurgitation' (a leaky heart valve) is a key focus for patients in the study.
Healthy volunteers will also participate to help validate the new method.
The goal is better timing for potential future treatments by understanding heart changes over time.

Who may be eligible?

To join this study, you need to be at least 18 years old.

There are two main groups for this study:

**Group 1: Healthy Volunteers** This group is for adults who don't have any known heart problems. You should have a healthy heart to take part.

**Group 2: Patients with Tetralogy of Fallot (ToF)** This group is for adults who have been diagnosed with Tetralogy of Fallot and had surgery for it in the past. You must also have been told you have a moderate or severe 'leaky heart valve' (pulmonary regurgitation) after your ToF repair.

There are also some reasons why you might not be able to join. For example, if you can't give your agreement to participate, or if the ultrasound images won't be clear enough. If you have a pacemaker or defibrillator that isn't safe for an MRI, you won't be able to join the patient group. Also, if you have other significant blockages or problems with the right side of your heart, you might not be suitable.

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 a diagnosis of Tetralogy of Fallot and had it repaired?
Have you been told you have moderate or severe pulmonary regurgitation after your repair?
Do you *not* have a pacemaker or defibrillator that isn't safe for an MRI?
Are your heart ultrasound images typically clear enough to be seen well?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special 3D ultrasound scan of your heart. This scan is similar to a regular ultrasound but provides more detailed 3D pictures. If you are in the patient group, you will also have an MRI scan of your heart, which is a standard procedure and provides very detailed images. The study will look at how your heart responds to treatment over a year, so you might have follow-up scans after this time. There are no new medications involved in this study. The study will continue until enough participants have been enrolled and all the necessary scans and tests have been completed.

Potential risks and benefits

Taking part in this study offers potential benefits by helping advance medical knowledge about managing Tetralogy of Fallot, which could lead to better care for patients in the future. There are generally very few risks associated with ultrasound and MRI scans, as they do not use radiation. However, MRI scans involve strong magnets, so people with certain metal implants cannot have them. You will be fully informed of all procedures and can 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.

Guys and St Thomas
Verified postcode
London, United Kingdom

Common questions

What is Tetralogy of Fallot (ToF)?

ToF is a serious heart condition that babies are born with, affecting the structure of the heart and how blood flows. It requires surgery early in life.

What does 'pulmonary regurgitation' mean?

It means the pulmonary valve, which controls blood flow from the heart to the lungs, is leaky, causing some blood to flow backward into the heart.

What is the new 3D ultrasound method?

It's an advanced way of using sound waves to create detailed, three-dimensional moving pictures of your heart, helping doctors see how well it's pumping.

Why is an MRI scan also used?

MRI is currently considered the most accurate way to measure the heart's chambers and pumping ability, so it's used as a 'gold standard' to check if the new ultrasound method is just as good.

Will I receive any new medicine in this study?

No, this study focuses on understanding and improving heart imaging techniques, so no new medicines are involved.