Not yet recruitingOBSERVATIONAL

Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure

This study is looking into new blood and urine tests for people who have heart failure. The main goal is to see if these new tests can accurately measure how much fluid is in a person's body. When too much fluid builds up, it's called congestion, and it can make heart failure worse, often leading to hospital visits. Doctors currently use other methods to check for congestion, but sometimes it's hard to spot early. By finding better ways to detect fluid build-up sooner, doctors might be able to adjust treatments earlier, which could help prevent someone from needing to go to the hospital. The study also wants to see if these tests can help doctors decide when it's safe for someone to go home after being in hospital for heart failure.

At a glance

Status

Not yet recruiting

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

140

Start

01 Jun 2024

Estimated completion

01 Dec 2025

Heart Failure Congestion

What is this study about?

Heart failure is a common condition where the heart doesn't pump blood as well as it should. This can lead to fluid building up in the body, such as in the lungs or legs. When this happens, it's called congestion. Congestion often causes people with heart failure to feel unwell and can lead to them needing to go into hospital. Unfortunately, being admitted to hospital for heart failure can sometimes have a lasting impact on a person's health.

Spotting congestion early can be tricky. Current tests have some limits, and often, by the time doctors see clear signs like swollen legs or crackling sounds in the lungs, the fluid build-up is already quite severe. If doctors had a more reliable way to detect this fluid build-up sooner, they could offer treatment earlier. This early treatment might help prevent hospital stays and improve how people feel overall. The study also hopes these new tests could help doctors decide if a patient being discharged from hospital is clear enough of fluid to go home safely.

This study will involve 140 people. Some will be in hospital for heart failure, and others will be waiting for a special heart device to be fitted. Participants will have standard check-ups like physical exams, heart scans (ECG and echocardiogram), and lung scans. They will also have blood and urine samples taken. By comparing these new test results with current methods, researchers hope to find better ways to measure and manage congestion in people with heart failure.

Key takeaways

This study is exploring new blood and urine tests for heart failure.
The goal is to better detect fluid build-up (congestion) in the body.
Early detection of congestion could help prevent hospital stays.
There are no new medicines or treatments being tested in this study.
Participation involves routine checks plus blood and urine sampling.
Understanding fluid levels better could help doctors manage heart failure.

Who may be eligible?

This study is looking for adults who are 18 years or older. You might be suitable if you have heart failure and are currently in hospital because of it, or if you're an outpatient needing a specific heart procedure called a right heart catheterisation. It also includes people with a certain type of heart failure who are about to have a special device (CRT) fitted, or those who have heart failure and need medicine given into their vein to help with fluid build-up.

There are several reasons why you might not be able to join. For example, if you're unable to give your consent, have been in this study before, or are taking part in another drug trial. You also couldn't join if you are pregnant or breastfeeding, have particular heart problems like an uncontrolled irregular heartbeat or severe valve disease, or if it's difficult to get clear images of your heart due to your body shape.

Certain other health conditions might also mean you can't take part. These include serious lung problems, severe liver disease, certain cancers, or recent lung infections like pneumonia. If you've had a recent blood clot in your lung, a collapsed lung, or a specific type of heart attack, you would also not be able to join this study.

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?
Are you able to provide your written consent to take part?
Are you not currently part of another clinical trial testing a new drug?
Are you not pregnant or breastfeeding?
Do you have good heart echo images (if applicable) and no major lung or liver diseases that might affect the results?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a few different assessments. These will include a check of your general health and medical history, a physical examination, and some heart tests like an electrocardiogram (ECG), which checks your heart's electrical activity, and an echocardiogram (a heart ultrasound). You will also have a scan of your lungs. Some people might also have a special procedure to measure pressures inside their heart, if this is already part of their usual care.

Crucially, you will be asked to provide blood samples and urine samples. The study is mainly about testing these new blood and urine tests. The researchers will compare the results of these new tests with the results from the more standard checks. We don't have a specific duration listed for how long you'll be involved in the study, but these assessments are usually done over a short period during a hospital stay or outpatient visit.

Potential risks and benefits

Taking part in this study won't directly improve your heart failure, as it's about testing new methods rather than new treatments. However, if these new tests prove useful, they could benefit future patients by leading to earlier and better management of fluid build-up. The main risks involve the usual discomfort of having blood samples taken or urine samples collected. If you have a right heart catheterisation, this is a standard medical procedure with its own risks, but it would only be done if your doctors had already decided you needed it as part of your regular care, not just for the study. You also have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (2)

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

Golden Jubilee National Hospital
Verified postcode
Clydebank, United Kingdom
Queen Elizabeth University Hospital
Verified postcode
Glasgow, United Kingdom

Common questions

What is 'congestion'?

Congestion means there's too much fluid built up in your body, often in your lungs or other areas, because your heart isn't pumping effectively. It's a common problem for people with heart failure.

Will I receive a new treatment in this study?

No, this study is not testing new treatments or medicines. It's focused on finding better ways to detect fluid build-up using new blood and urine tests.

How many times will I need to visit the hospital?

The study assessments usually take place during a hospital stay for heart failure, or during an outpatient visit if you're having a specific heart procedure done. It's not expected to involve many extra visits beyond your usual care.

Will I get my test results back?

The study aims to gather information for research purposes to develop new diagnostic tools. You won't automatically receive individual research test results as they are for study analysis, not for immediate medical decisions for you personally.

What will happen to my blood and urine samples?

Your samples will be used by the researchers to carry out the new blood and urine tests to see how accurately they can measure congestion. They will be handled confidentially and used solely for the study's scientific goals.

How to find out more

Kieran F Docherty, MBChB, PhD

kieran.docherty@glasgow.ac.uk 01413301672 Official trial record

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