Active not recruitingNAINTERVENTIONAL

HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device

This study is looking at a new device called Heartfelt, which aims to help people with heart failure. Heart failure can cause swelling in the legs and shortness of breath due to fluid build-up. Catching these signs early is really important to help manage the condition and potentially avoid going into hospital. The Heartfelt device sits by your bed and simply scans your feet to detect tiny changes in their size. These changes can be an early warning of fluid build-up, even before you notice them yourself. This study wants to see if this easy-to-use device can effectively help doctors make quicker decisions about your care, helping to keep you healthier and out of hospital. It's for adults aged 18 and over who have heart failure.

At a glance

Status

Active not recruiting

Phase

Sponsor

Heartfelt Technologies

Enrolment target

186

Start

11 Jul 2024

Estimated completion

31 Jan 2027

Heart Failure

What is this study about?

Heart failure is a condition where your heart doesn't pump blood as well as it should. This can lead to fluid building up in your body, often causing swelling in your legs and ankles, and making you feel breathless. These signs often appear before you even feel really unwell, and catching them early is key to managing your condition effectively and sometimes preventing a trip to the hospital. Your doctors often suggest keeping an eye on your weight, checking your ankles for swelling, and noting any changes in your breathing. If you report these symptoms quickly, your healthcare team can often adjust your medication, like water pills (diuretics), to help remove the extra fluid and keep you feeling better.

However, it can sometimes be difficult to keep track of these changes every day. This is where the Heartfelt device comes in. It's a new, simple device designed to make this easier for you. You just place it by your bedroom floor, and it quietly scans your feet for any slight changes in size. These small changes can be an early sign that fluid is building up in your body, even before you might notice it yourself. The device takes pictures of your feet only, respecting your privacy.

The main goal of this study, called HF-TRACK, is to find out how well this Heartfelt device actually works in everyday life. We want to see if it can help doctors make quicker and better decisions about your care, potentially helping to adjust your treatment when needed. This could mean fewer hospital stays for people with heart failure. This study was actually designed with help from people who have heart failure or care for someone with the condition, to make sure it's as helpful as possible.

Key takeaways

Tests a new device to help manage heart failure.
Aims to detect early signs of fluid build-up to prevent hospital stays.
The device is easy to use and scans your feet automatically.
Study lasts for six months with ongoing medical care.
Designed with input from people who have heart failure.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older with a heart failure diagnosis that was made at least three months ago. You should also be taking water pills (diuretics) every day. A key part of qualifying is having been in hospital due to heart failure with leg swelling, or needing strong fluid treatments, at least once in the last year or so.

We're especially looking for people who might find it difficult to regularly weigh themselves, or who are at a higher risk of needing to go to hospital again for their heart failure.

However, you can't take part if you have bandages on your legs every day, have had both feet amputated, use a wheelchair regularly inside your home, or are always in bed. Also, if you’re currently in another study or evaluation that might affect the results of this one, or are pregnant, you won't be able to join.

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 heart failure diagnosis made at least 3 months ago?
Do you take water pills (diuretics) every day?
Have you been in hospital for heart failure with leg swelling in the last year?
Do you find it hard to regularly check your weight or think you're at higher risk of hospital readmission for heart failure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to sign an agreement, which can be done online. This study will last for six months. During this time, you will be given the Heartfelt device to use at home. This device sits on your bedroom floor and quietly scans your feet to monitor for fluid changes. You won't need to do anything else with the device; it works automatically. You'll also continue with your usual heart failure care, including any medications you currently take. Throughout the study, you'll be asked to complete some questionnaires. We'll be looking at how well the device helps your doctors manage your heart failure and reduce the need for hospital visits. After six months, we will compare the information from people using the device to those receiving standard care. Your health will be monitored throughout the study period.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as having your heart failure signs monitored more closely, which might help your doctors adjust your treatment earlier to prevent worsening symptoms and potentially reduce hospital stays. The device is designed to be very simple to use and shouldn’t add to your daily tasks. As with any study, there could be unforeseen risks, but the device is non-invasive and just scans your feet. Your privacy is protected as it only captures images of your feet. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Ridings Medical Group
Verified postcode
Brough, United Kingdom
Dr R Raut & Partnership (General Practice)
Verified postcode
Hull, United Kingdom
Croydon Health Services NHS Trust
Verified postcode
Croydon, United Kingdom
West Suffolk NHS Foundation Trust
Verified postcode
Bury St Edmunds, United Kingdom
Modality East Surrey Medical Practice
Verified postcode
Horley, United Kingdom
Modality Partnership Airedale, Wharfedale & Craven:
Verified postcode
Keighley, United Kingdom
Pillsorted Ltd
Verified postcode
Cambridge, United Kingdom
DR GT Hendow Surgery
Verified postcode
Hull, United Kingdom
Sutton Manor Pharma Services
Verified postcode
Hull, United Kingdom
James Alexander Family Practice
Verified postcode
Hull, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as well as it should. This can lead to symptoms like feeling tired, breathless, and having swollen legs.

What does the Heartfelt device do?

The Heartfelt device sits on your bedroom floor and scans your feet to find very early signs of fluid build-up, which can be an early warning sign of worsening heart failure.

Will using the device replace my regular doctor's visits?

No, the device is meant to work alongside your usual care, not replace it. It gives your healthcare team more information to help manage your condition.

How long will I be in the study?

The study lasts for six months, during which you will use the Heartfelt device at home and complete some questionnaires.

Is the device safe to use?

Yes, the device is non-invasive, meaning it doesn't go inside your body. It just scans your feet and is designed to take images of your feet only, maintaining your privacy.