VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study
Heart failure affects many people in the UK. If your heart isn't pumping properly, a device called Cardiac Resynchronisation Therapy (CRT) can be fitted to help it work better. However, it doesn't help everyone, and the procedure carries risks like bleeding or infection. This study wants to find a way to predict who will benefit most from a CRT device before it's put in. They will use advanced computer models, sometimes called 'digital twins,' to create a virtual version of a patient's heart and see how it might react to the device. By doing this, doctors hope to avoid unnecessary procedures for patients who might not benefit, making treatment safer and more effective.
At a glance
What is this study about?
Heart failure is a common condition where your heart doesn't pump blood around your body as well as it should. About half of these cases involve what doctors call 'heart failure with reduced ejection fraction,' meaning the heart muscle isn't squeezing properly. If the two main pumping chambers of your heart (the ventricles) aren't working in perfect sync, a special device called Cardiac Resynchronisation Therapy (CRT) can be implanted. This device helps your heart's chambers pump together, which can make you feel better and help you live longer.
The CRT device involves placing thin wires into your heart through blood vessels. The problem is, this procedure doesn't help everyone. Around a third of people don't get any better, and another third only see a small improvement. Doctors currently can't accurately predict who will respond well. This means some people might go through the procedure, with its potential risks like bleeding or infection, without getting any benefit. This study aims to make this process safer and more effective.
To help solve this, researchers are exploring the use of advanced computer models. Imagine a 'digital twin' – a virtual, personalised model of your heart and blood vessels, created using artificial intelligence. This digital twin can help predict how your heart might react to a CRT device, without you actually having the procedure first. This study will involve 30 patients who are already planned to have a CRT device. By comparing what the digital twin predicts with how patients actually respond, researchers hope to develop a way to accurately tell which patients will benefit most, avoiding unnecessary procedures and risks.
Key takeaways
- Aims to predict who benefits from CRT devices.
- Uses advanced 'digital twin' computer models of the heart.
- Could help avoid unnecessary procedures and risks in the future.
- Involves pre-procedure tests and 3 and 6-month follow-up checks.
- Doesn't involve new medications, only observation.
Who may be eligible?
This study is looking for around 30 people who have been told by their heart specialist (cardiologist) that they need a CRT device implanted because of their heart failure.
You would need to be over 18 years old and have this specific type of heart failure. You also need to be able to walk a certain distance for a simple test. There are some health conditions or situations that would mean you couldn't join the study, such as being pregnant, having certain types of kidney disease, or having had a major heart event or surgery very recently.
Also, if you have any metal fragments in your body that would make an MRI scan unsafe, or if you are already taking part in another study that involves active treatment, you wouldn't be able to join this one.
- Are you over 18 years old?
- Has your heart specialist recommended a CRT device for your heart failure?
- Are you able to walk for a 6-minute test?
- Are you not pregnant?
- Have you not had a heart attack, heart surgery, or valve procedure in the last 3 months?
- Do you not have certain severe kidney problems or particular metal in your body?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first visit University College London (UCL) for several tests before your CRT device is fitted. These tests include a blood test, a urine test, a special heart scan called an MRI, an ultrasound of your heart, a short 5-minute heart recording, and a 6-minute walking or stepping test.
After you have your CRT device put in, your progress will be checked with more tests. You'll have another blood test, a 6-minute walking/stepping test, and a heart ultrasound scan. These follow-up tests will happen twice: once about 3 months after your procedure and again about 6 months after. There are no extra medications involved in this study; it's all about observing your response to the CRT device and comparing it to the digital twin predictions.
Potential risks and benefits
Locations (1)
- Royal Free Hospital NHS Trust (RFH)London, United Kingdom
Common questions
What is 'heart failure with reduced ejection fraction'?
It means your heart's main pumping chambers aren't squeezing as strongly as they should, making it harder for your heart to pump enough blood.
What is a 'digital twin'?
It's like a personalised computer model of your heart, created using advanced technology, which can help predict how you might respond to treatments.
Will I have to take new medicine for this study?
No, this study doesn't involve any new medicines. It's about monitoring your response to a device you're already scheduled to receive.
What kind of tests will I have?
You'll have blood tests, urine tests, heart scans (MRI and ultrasound), a heart recording, and a walking/stepping test.
How long will I be in the study?
You'll have initial tests before your procedure, then follow-up tests at 3 and 6 months after your CRT device is implanted.
How to find out more
Gabriella Captur
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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