RecruitingPhase IIInterventional

Role of at-home treatment of heart failure and kidney disease patients with under-the-skin injection of "furosemide" for fluid removal

This study explores a new way to treat fluid build-up in people with both heart and kidney disease. Often, patients need to go to hospital for an IV drip of medicine called furosemide to remove extra fluid. This research will test if a small pump, worn at home, can deliver furosemide under the skin to help remove excess fluid and prevent hospital stays. Hospital visits can be stressful and carry risks like infections. The study aims to find out if this home treatment is effective and safer, giving patients more control and comfort while managing their condition. It's for adults aged 18 and over with both conditions.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

St George’s University Hospitals NHS Foundation Trust

Enrolment target

200

Start

01 Nov 2025

Estimated completion

01 Oct 2028

Heart failure with chronic kidney disease, with fluid overload

What is this study about?

If you have heart failure and kidney disease, your body can sometimes build up too much fluid. This can make you feel breathless and cause swelling in your legs and other parts of your body. Usually, when this happens, you might need to go to the hospital to get a medicine called furosemide given directly into your veins to remove this extra fluid. This can be a disruptive and sometimes risky experience, as hospital stays can lead to infections or sometimes affect your kidneys more.

This study is looking into a different way to tackle this problem. Instead of going to the hospital for an IV drip, we want to see if you can manage the fluid build-up at home. The study will test a small device that delivers furosemide under your skin using a tiny needle, similar to how some people manage other conditions at home. The idea is that you'd use this pump for a few hours each day for about five days when you start to notice fluid building up.

The main goal of this research is to find out if using this home treatment is just as good, or even better, at removing excess fluid and stopping you from needing to go to the hospital. By staying at home, we hope to make managing your condition more comfortable and reduce some of the risks associated with hospital admissions. We want to empower patients to feel more in control of their health.

Key takeaways

Tests a new way to treat fluid build-up at home to avoid hospital.
Uses a small pump to give furosemide under the skin.
Aims to make managing heart and kidney conditions more comfortable.
Involves tracking your symptoms and health at home.
You might be chosen for home treatment or usual hospital care.
The study team will support you and monitor your health closely.

Who may be eligible?

This study is looking for adults aged 18 or older who have both heart failure and kidney disease. To join, you must have been in hospital for your condition in the last year and be able to give your clear agreement to take part. You (or someone who helps care for you) also need to be able to use the home treatment pump and do some simple health checks at home.

There are also some reasons why you might not be able to join. For example, if you already have very severe kidney disease and are on dialysis, or if you have a serious lung condition that causes low oxygen levels. Other reasons include certain heart rhythm problems, if you're receiving end-of-life care, are pregnant or breastfeeding, or if you're allergic to the study medication or similar medicines.

For those who do join, if you start to get build-up of fluid, there are additional checks. You wouldn't be able to receive the home treatment if your blood pressure is very low, your oxygen levels are too low, you have a high fever, a very fast heart rate, new heart rhythm issues, or if your potassium levels are too low. Your medical team would also decide if you're too unwell and need hospital care instead.

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 both heart failure and kidney disease?
Have you been admitted to hospital for your condition in the last year?
Are you, or your carer, able and willing to use a home treatment device and do daily health checks?
Are you not currently on dialysis?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join the study, it will happen in two main stages, running at the same time. In the first stage, we'll teach you how to spot the early signs of fluid build-up, like gaining weight or feeling more breathless and swollen. We’ll ask you to get in touch with our team if this happens, and we'll also call you every two months to check in.

If you experience fluid build-up, and are among the first 80 eligible participants, you might be randomly chosen to either receive the home treatment or continue with your usual care, which would involve going to the emergency department if needed, just as you would normally. If you're in the home treatment group, we’ll train you on how to use the special pump. You’ll wear this small pump, which has a tiny needle under your stomach skin, for about 5 hours a day, for 5 days.

Throughout the study, you'll need to do daily checks like measuring your weight, blood pressure, and oxygen levels; we'll give you the equipment for this. You’ll also have two blood tests during the 5 days of home treatment, which our team will do at your home. We'll also call you daily during this time. The study is expected to run from September 2025 to November 2028.

Potential risks and benefits

We hope this study will show that treating fluid build-up at home with the furosemide pump can effectively ease your symptoms and help you avoid a hospital stay. Staying at home can be more comfortable and reduce risks like infections that can happen in hospitals. However, there are some things to consider. You will need to learn how to use the pump and do daily health checks, which might take some time and effort. The pump is small and can be worn under clothes, so you can still go about your day. There is a small risk of side effects from furosemide, like low potassium levels or kidney problems, but these are also risks if you were to receive the medicine in hospital, and we will monitor you closely with blood tests to catch any issues early. We will also train you on when you should go to the hospital, and our team will be available every day if you have questions or problems. You are free to stop participating at any time.

Locations (1)

-
Approximate
-, England

Common questions

What is furosemide and how will it be given?

Furosemide is a medicine that helps remove excess fluid from your body. In this study, it will be given using a small pump that delivers the medicine under your skin, instead of through a drip in your vein at the hospital.

Why is this study important?

This study aims to find out if treating fluid build-up at home can prevent hospital stays, making it more convenient and potentially safer for people with heart and kidney problems.

Will I have to go to hospital during the study?

The goal is to help you avoid hospital. If you're in the home treatment group, you'll manage your fluid at home. However, if you become very unwell, you would still need to go to hospital, and we will teach you when this is necessary.

Who is funding this research?

The study is funded by a UK organisation called the National Institute for Health and Care Research.

What if I change my mind about taking part?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Debasish Banerjee

renal.researchteam@stgeorges.nhs.uk +44 (0)208 725 1673 Official trial record

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