RecruitingInterventional

A study testing a new heart scan method to improve pacemaker treatment for heart failure

This study is testing a new way to help people with heart failure who are being considered for a special pacemaker treatment called Cardiac Resynchronisation Therapy (CRT). CRT helps the heart pump better, but it doesn't work for everyone. Researchers want to use a new measurement from a heart ultrasound (echocardiogram) called 'EF1' to better predict who will benefit most from this pacemaker. They hope this will help doctors choose the right patients and adjust the pacemaker settings more effectively. The study involves regular heart scans and check-ups over several years.

At a glance

Status

Recruiting

Sponsor

King's College London

Enrolment target

400

Start

01 Aug 2025

Estimated completion

31 Jul 2027

Cardiac resynchronisation therapy, heart failure

What is this study about?

Heart failure means your heart isn't pumping blood as well as it should. Sometimes, medicines alone aren't enough, and doctors might suggest a special pacemaker called Cardiac Resynchronisation Therapy (CRT). This pacemaker helps the heart's pumping chambers work together more effectively. However, it doesn't help every patient, so doctors are looking for better ways to figure out who will benefit the most.

This study is investigating a new measurement, taken during a standard heart ultrasound (echocardiogram), called 'EF1'. This measurement looks at how well the heart starts to pump blood. Researchers believe EF1 could be a very useful tool to predict whether a patient will respond well to CRT. If they can accurately predict this, it means more people will get the right treatment faster.

The main goal is to see if using this new EF1 measurement can help improve how patients with heart failure respond to their CRT pacemaker. Participants will have regular heart scans, and the study will follow them for several years to see if those guided by EF1 have better results. The findings could help doctors worldwide improve pacemaker treatment for many people with heart failure.

Key takeaways

This study evaluates a new method to improve pacemaker treatment for heart failure patients.
It uses a new measurement from heart scans (echocardiograms) called 'EF1'.
The goal is to better select patients who will benefit most from their special pacemaker.
Participation involves ongoing heart scans and follow-up appointments over several years.
The study aims to improve future care for heart failure patients.
It is funded by the National Institute for Health and Care Research (NIHR).

Who may be eligible?

You might be able to join this study if you are over 18 years old and are currently receiving the best possible medicine treatment for your heart failure. You also need to meet the standard health guidelines that doctors use to decide if someone should have a special pacemaker called Cardiac Resynchronisation Therapy (CRT). This includes having certain measures of your heart function and electrical activity.

There are some reasons why you might not be able to join. For example, if you have other serious health problems that might shorten your life significantly, or if you've had a major heart event recently (in the last six weeks). You also can't take part if you have certain heart valve problems, need continuous treatment for heart failure that involves drips, or if it's difficult to get clear images from your heart ultrasound.

It's important that you understand English well, so you can give your full permission to join and understand everything about the study. You also can't be taking part in another study that involves new treatments at the same time.

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 over 18 years old?
Are you currently taking the best available medicines for your heart failure?
Do you meet the usual guidelines for getting a special pacemaker (CRT) for heart failure?
Do you not have other serious health problems that would significantly shorten your life?
Have you not had a major heart event, like a heart attack, in the last 6 weeks?
Are you able to provide clear images during a heart ultrasound scan?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll mostly continue with your usual care for heart failure and your pacemaker. The main difference is that you'll have extra measurements taken during your regular heart ultrasound scans. These extra measurements will help the researchers understand how the new 'EF1' method predicts how well your pacemaker is working.

You'll have follow-up appointments at 6 months, 12 months, and 36 months after starting the study. At these appointments, your heart health and pacemaker settings will be checked. If, after 6 months, your heart hasn't improved as expected, your pacemaker settings might be adjusted. Another check-up would then happen 6 months after that adjustment. The total duration of your involvement could be several years, as the study plans to follow people for at least 36 months.

Potential risks and benefits

While taking part in this study might not directly benefit your health right now, the information gathered could significantly help future patients with similar heart conditions. The medical tests involved, like the heart ultrasound (echocardiogram), are already a standard and safe part of your routine care and are very unlikely to cause you harm. Adjusting your pacemaker's timing settings is also a normal part of its management. This study simply provides a new way to help doctors decide on the best settings. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (4)

Guy's and St. Thomas' NHS Foundation Trust
City only
London, United Kingdom
Barts Health NHS Trust
City only
London, United Kingdom
Kings College Hospital
Approximate
London, United Kingdom
Leeds Teaching Hospitals NHS Trust
City only
Leeds, United Kingdom

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It can make you feel tired or breathless.

What is a CRT pacemaker?

A CRT pacemaker is a special device implanted in your chest that helps the different parts of your heart beat in a more synchronised way, improving its pumping action.

What is an echocardiogram?

An echocardiogram is a type of ultrasound scan that uses sound waves to create moving pictures of your heart. It's a common and safe test.

Will I have to pay to participate?

No, you will not have to pay to participate in this study. It's funded by the National Institute for Health and Care Research (NIHR).

What if my pacemaker settings are changed?

Adjusting pacemaker settings is a normal part of your care. In this study, if there's no improvement after 6 months, an adjustment might be made, and your progress will be checked again.

How to find out more

Haotian Gu

haotian.gu@kcl.ac.uk +44(0)2071884700 Official trial record

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