RecruitingNAINTERVENTIONAL

Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure

Doctors are testing a new way to manage fluid in people with heart failure who are in the hospital because their symptoms have worsened. This new way uses a device called Bioimpedance Analysis (BIA) to measure body fluid. The study wants to find out if using BIA helps reduce the need for extra medication (diuretics) to remove fluid, or if it stops people from needing to come back to the hospital for heart failure within 90 days of going home. Half the patients will have their treatment guided by BIA results, while the other half will receive standard care. All participants will have follow-up checks including blood tests and a questionnaire after discharge.

At a glance

Status

Recruiting

Phase

Sponsor

Mid and South Essex NHS Foundation Trust

Enrolment target

255

Start

30 Dec 2024

Estimated completion

01 Dec 2026

Heart Failure Decompensated Heart Failure

What is this study about?

Heart failure is a condition where your heart struggles to pump blood effectively, which can lead to fluid building up in your body. When this fluid builds up too much, it can make your symptoms much worse, leading to a hospital stay. Managing this fluid carefully is really important, but it's often tricky for doctors to know exactly how much fluid a person has.

This study is looking at whether a special, easy-to-use tool called Bioimpedance Analysis (BIA) can help doctors do a better job at managing this fluid. BIA measures your body's fluid levels very accurately. The researchers want to see if using BIA to guide treatment can help patients recover better, reduce the number of times they need extra medication for fluid, or even stop them from having to come back to the hospital in the 90 days after they've been discharged.

To find this out, people joining the study will be split into two groups. One group will have their fluid treatment guided by the BIA measurements throughout their hospital stay. The other group will receive the usual care, where doctors manage fluid based on their standard practice. Both groups will be checked closely to see if BIA makes a difference in how well patients manage their heart failure.

Key takeaways

This study evaluates if a fluid measurement tool (BIA) can improve heart failure care.
It aims to reduce re-hospitalizations and the need for extra fluid-removing medication.
Participants are randomly assigned to either BIA-guided or standard care.
All will have a follow-up visit 2-4 weeks after leaving the hospital.
The BIA test is a safe, non-invasive way to measure body fluid.
Your medical care will always prioritize your well-being, regardless of your group assignment.

Who may be eligible?

This study is looking for adults aged 18 or older who have been admitted to the hospital because their heart failure symptoms have suddenly gotten worse. It doesn't matter what type of heart failure you have, or how well your heart is pumping – you could still be eligible.

However, there are some reasons why you might not be able to join. For example, if you're receiving end-of-life care or are expected to live less than three months, or if you're in intensive care, this study might not be suitable for you. Also, if you're already in another trial testing new heart failure treatments or if you need kidney dialysis, you won't be able to take part.

Lastly, it's really important that you understand what the study involves and are happy to give your permission to participate. If you're unable or unwilling to do so, 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?
Are you currently in the hospital because your heart failure symptoms have worsened?
Are you able and willing to understand the study and agree to take part?
Are you not in intensive care, needing kidney dialysis, or actively participating in another new drug/treatment trial?
Do you expect to live for more than three months, and are not on an end-of-life care plan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly put into one of two groups. Being "randomly assigned" means it's like flipping a coin to decide which group you're in, so it's fair. Both groups will have a BIA measurement taken within 24 hours of arriving at the hospital.

If you're in the "BIA-Guided Treatment Group," you'll have more BIA measurements throughout your hospital stay. The results from these measurements will be used by your doctors to decide how best to manage your fluid with medication. If you're in the "Standard Care Group," you'll also have BIA measurements taken when you arrive and when you leave the hospital, but your doctors won't see these results, and your fluid management will be done as usual.

After you leave the hospital, everyone in the study will have a follow-up visit with the research team. This visit will take place about 2 to 4 weeks after you've gone home. During this visit, you'll have standard health checks, some blood tests, and be asked to fill out a questionnaire about how your heart failure is affecting your quality of life. The total duration of your active participation, including hospital stay and follow-up, will be around 90 days to see how you're doing after discharge.

Potential risks and benefits

Taking part in this study might offer a potential benefit if you are in the BIA-guided group, as the new fluid management approach could potentially lead to better control of your heart failure symptoms and reduce the chance of needing extra treatment or returning to the hospital. However, there's no guarantee this will happen, and the other group will receive standard, established care. The BIA test itself is non-invasive and generally considered very safe, with minimal risks. You are free to withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your usual medical care.

Locations (1)

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

Basildon University Hospital
Verified postcode
Basildon, United Kingdom· Recruiting

Common questions

What is Bioimpedance Analysis (BIA)?

BIA is a simple, painless test that measures the fluid in your body. It uses small electrical signals, similar to how a home scale might measure body fat, to get an idea of your fluid levels.

Will I know which group I'm in?

Yes, you will be told which group you are assigned to – either the BIA-guided treatment group or the standard care group. This helps you understand how your care is being carried out.

How often will I have BIA tests?

If you're in the BIA-guided group, you'll have BIA tests throughout your hospital stay. If you're in the standard care group, you'll have BIA tests at the start and end of your hospital stay only.

What happens if I need extra treatment?

Regardless of which group you are in, your medical team will always ensure you receive the best care. If you need additional treatment for your heart failure, you will receive it as needed.

Will this study affect my usual medication?

Your doctors will continue to manage your heart failure medication as needed. For one group, the BIA results will help guide the amount of diuretics (water pills) you receive.

How to find out more

Henry Oluwasefunmi Savage, MD FRCP

henry.savage@nhs.net +44 01268524900 Official trial record

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