Not yet recruitingOBSERVATIONAL

Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation

This study for people with heart failure and atrial fibrillation is looking for better ways to measure how well the heart is working. Currently, methods to check heart pressure are not always accurate for those with both conditions, making it hard to diagnose and treat them effectively. Researchers are using new ultrasound techniques, combined with artificial intelligence, to get more precise and faster measurements of heart pressure. The goal is to develop improved tools that can predict who is at higher risk of hospitalisation or death due to heart failure. Ultimately, this could lead to more accurate diagnoses, better treatment plans, and improved quality of life for many patients.

At a glance

Status

Not yet recruiting

Sponsor

Oslo University Hospital

Enrolment target

400

Start

01 Feb 2026

Estimated completion

01 Dec 2029

Heart Failure (HF)Atrial Fibrillation (AF)

What is this study about?

Heart failure and atrial fibrillation are two common heart conditions that often affect people at the same time. When you have both, the risk of needing hospital care or facing serious health problems increases significantly. At the moment, it can be tricky for doctors to accurately assess how severely the heart is affected in these cases, which makes it harder to choose the best treatment or know who might be at greater risk in the future.

One key thing doctors look at is the 'filling pressure' in the left side of the heart. If this pressure is too high, it means the heart struggles to fill with blood properly. This can lead to symptoms like feeling out of breath or having fluid build-up in your body. While doctors often use ultrasound scans (called echocardiograms) to estimate this pressure, the usual methods aren't very reliable for someone who also has atrial fibrillation. This study aims to fix that problem.

The research team is testing new ultrasound techniques, using clever computer technology (like artificial intelligence), to get more accurate and faster measurements of this heart pressure. By combining new ways of looking at heart function with established methods, they hope to create a tool that works well for people with both heart failure and atrial fibrillation. They will then see if these improved measurements can help predict which patients might be at highest risk of needing hospital treatment or having other serious problems related to their heart condition. The study is taking place in several hospitals across different countries to make sure the results are strong and can help many different patients.

Key takeaways

Targets adults with both heart failure and atrial fibrillation.
Aims to improve heart pressure measurements using new ultrasound and AI.
Could lead to better diagnosis and more effective treatment in the future.
Involves detailed heart scans and measurements during scheduled procedures.
No new treatments are provided, focus is on diagnostic tools.
Follow-up for three years to track health outcomes.

Who may be eligible?

This study is looking for adults aged 18 or over who have atrial fibrillation (which can be occasional, constant, or long-lasting) and are already scheduled for a heart procedure called a right or left heart catheterisation for medical reasons. You would need to be able to have an ultrasound scan and the heart pressure measurement within 8 hours of each other, without changing any of your heart medications in between.

There are certain reasons why someone might not be able to join the study. For instance, if you have certain types of severe valve problems in your heart, have a mechanical heart valve, or have very fast and uncontrolled atrial fibrillation. Other reasons include if you have had a heart transplant, are pregnant, or have other serious illnesses that make measuring heart pressure unreliable or mean you have a poor outlook.

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 atrial fibrillation (occasional, constant, or long-lasting)?
Are you already scheduled for a heart catheterisation procedure?
Can you have an ultrasound scan and the heart catheterisation within 8 hours of each other, without changing heart medications?
Do you have any serious conditions like severe valve problems, a heart transplant, or are pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be joining a study that lasts for about three years. You’ll have an ultrasound scan (echocardiogram) either just before, during, or right after your scheduled heart catheterisation procedure. During the catheterisation, doctors will measure the pressure inside your heart. It's important that you don't change any of your heart medications between your ultrasound scan and the catheterisation, and these two procedures should happen within 8 hours of each other. The research team will also collect routine information like your blood pressure, a standard blood test, and an electrical recording of your heart (ECG). Some participants might also have an exercise test to see how their heart pressure changes with activity. You'll be followed up for three years to see how your health changes over time.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to new knowledge that could improve diagnosis and treatment for people with heart failure and atrial fibrillation in the future. While there are no direct health benefits to you personally from taking part, the information gathered could lead to earlier and more personalised care for many. The measurements taken, such as the ultrasound and heart catheterisation, are part of routine medical care for your condition, so the study itself doesn’t add new invasive procedures. All medical procedures carry some risks, but the study procedures are being carried out as normal clinical care. You are free to withdraw from the study at any time without affecting your medical care.

Locations (15)

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

Cleveland Clinic
Verified postcode
Cleveland, United States
Methodist DeBakey Heart and Vascular Center
Verified postcode
Houston, United States
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
Verified postcode
Aalst, Belgium
Catholic University of Leuven
Verified postcode
Leuven, Belgium
Laboratory Signal Processing and Image, Department of Cardiology
Verified postcode
Rennes, France
Service de Cardiologie, Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France
Nagoya City University Graduate School of Medical Sciences
Verified postcode
Nagoya, Japan
Ehime University
Verified postcode
Tōon, Japan
University of Auckland
Verified postcode
Auckland, New Zealand
Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital
Verified postcode
Oslo, Norway
Carol Davila University of Medicine and Pharmacy
Verified postcode
Bucharest, Romania
The Department of Cardiology at the Ljubljana University Medical Centre
Verified postcode
Ljubljana, Slovenia

Common questions

What is the main goal of this study?

To find better ways to measure heart pressure in people with both heart failure and atrial fibrillation, to improve diagnosis and treatment.

What is an 'echocardiogram'?

It's a type of harmless ultrasound scan that creates pictures of your heart, showing how it's beating and pumping blood.

What does 'filling pressure' mean?

It's the pressure inside your heart when it's filling with blood. If it's too high, it means your heart struggles to take in enough blood.

Will I get any new treatments if I join?

No, this study is about improving diagnostic methods, not testing new treatments. Your medical care will continue as usual.

What is 'Artificial Intelligence' doing in this study?

AI will help the researchers analyse the ultrasound measurements to find the most useful information and make the process faster and more accurate.

How to find out more

Lars-Egil Reine Hammersboen, Medical doctor

lerhammersboen@gmail.com +4790116941 Official trial record

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