Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
This study is testing a new device called Heartfelt for people living with heart failure. Heart failure can cause fluid to build up, leading to swelling and breathlessness. The Heartfelt device takes daily pictures of your feet and lower legs to check for early signs of this fluid build-up, without you needing to do anything extra. If changes are seen, your medical team will be alerted quickly. We want to see if using this device, alongside your usual NHS care, can improve your quality of life and reduce the number of heart failure-related hospital visits, compared to just having usual care. The study involves 300 people across the UK.
At a glance
What is this study about?
If you have heart failure, you might experience fluid building up in your body, especially in your legs, which can cause swelling and make you feel breathless. Catching these early signs is really important, as it can help prevent your condition from getting worse and needing a hospital stay. While doctors often advise checking your weight and symptoms regularly, it can sometimes be hard to keep track of these things every day.
This study is looking at a new, easy-to-use device called Heartfelt. It works by taking pictures of your feet and lower legs each day to measure changes in swelling. You don't need to do anything special; the device does it all automatically. If it spots any important changes, it will send an alert to your medical team, so they can act quickly if needed. We want to find out if using this device, in addition to your usual NHS care, makes a real difference to your quality of life and reduces how often you need to go to hospital for heart failure problems.
Around 300 people from different NHS hospitals and GP practices across the UK will take part. Participants will be split into two groups by chance: one group will receive their usual NHS care, and the other will get their usual care plus the Heartfelt device. The study will also help us understand how easy the device is to use and if it offers good value for money for the NHS. Your involvement will help shape future care for people with heart failure.
Key takeaways
- This study tests a new device for monitoring heart failure fluid build-up.
- The Heartfelt device takes daily pictures of your legs to detect swelling early.
- It aims to improve quality of life and reduce hospital stays for heart failure.
- 300 people across the UK will take part, split into two groups.
- One group gets usual care, the other gets usual care plus the device.
- Your input will help improve future heart failure care.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been diagnosed with heart failure. You also need to have swelling in your legs that has been noted by a doctor or that you've noticed yourself, and you must live in the UK in a home where the Heartfelt device can be set up.
Beyond these general points, there are a few more specific things that would make you suitable. For example, if you are currently taking a certain dose of water tablets (diuretics) every day and have recently been to hospital for a heart or breathing problem. Another possibility is if you take a specific type of heart medication called an SGLT2 inhibitor and sometimes take water tablets only as needed, and have either had multiple recent hospital stays for heart failure or a specific blood test result.
Finally, if you have an implanted device that already monitors your heart's fluid levels, you might also be eligible to join this study. The research team will review all these details to see if the study is right for you.
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 heart failure?
- Have you experienced moderate to severe swelling in your legs?
- Do you live in the UK in a home suitable for the device?
- Are you taking specific daily water tablets or other heart medications/have a specific heart monitoring device?
What does participation involve?
If you join this study, you will be in one of two groups. One group will continue with their usual heart failure care from the NHS, including regularly checking their weight and symptoms. The other group will receive their usual care, plus the Heartfelt device for monitoring. The device involves taking daily images of your feet automatically; you won't need to do anything extra.
The study will look at various aspects, including your quality of life, how well the device collects useful information, and how often you use healthcare services. The researchers will also be interested in how easy the device is for you to use and how your medical team responds to any alerts. The total duration of your participation in the study will be explained by the research team.
Potential risks and benefits
Locations (18)
- Buckinghamshire Healthcare NHS TrustVerified postcodeAylesbury, United Kingdom· Recruiting
- Croydon Health Services NHS TrustVerified postcodeCroydon, United Kingdom· Recruiting
- Hertfordshire Community NHS TrustVerified postcodeWelwyn Garden City, United Kingdom· Recruiting
- Holderness HealthVerified postcodePatrington, United Kingdom· Recruiting
- Kent Community Health NHS Foundation TrustVerified postcodeAshford, United Kingdom· Recruiting
- Lincolnshire Community Health Services NHS TrustVerified postcodeLincoln, United Kingdom· Recruiting
- North Tees & Hartlepool NHS Foundation TrustVerified postcodeHardwick, United Kingdom· Recruiting
- Ulster HospitalVerified postcodeBelfast, United Kingdom· Not yet recruiting
- Princess of Wales HospitalVerified postcodeBridgend, United Kingdom· Recruiting
- Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)Verified postcodeGlasgow, United Kingdom· Recruiting
- Hull University Teaching Hospitals NHS TrustVerified postcodeHull, United Kingdom· Not yet recruiting
- St George's HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should. This can lead to symptoms like tiredness, shortness of breath, and swelling in your legs.
What is the Heartfelt device?
It's a new device that takes daily pictures of your feet and lower legs to measure changes in swelling. This helps spot fluid build-up early without you having to do anything.
Will I know which group I am in?
You will generally not know which group you are in at the start, as participants are randomly assigned. However, if you are using the device, you might see technical messages from it.
How long will I be in the study?
The full length of time you would be involved in the study will be clearly explained by the study team if you are invited to participate.
Will my usual heart failure care change?
No, whether you get the device or not, you will continue to receive your standard heart failure care from the NHS, as recommended by your doctor.
How to find out more
Oriane Chausiaux
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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