Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation: A Prospective Multicenter Study
Trial ID: NCT07436299
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-02
Completion date: 2029-12
Sponsor: Oslo University Hospital
Collaborators: The National Association for Public Health, Norway
Conditions: Heart Failure (HF); Atrial Fibrillation (AF)
Locations: Cleveland Clinic; Methodist DeBakey Heart and Vascular Center; Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Catholic University of Leuven; Laboratory Signal Processing and Image, Department of Cardiology; Service de Cardiologie, Hôpitaux Universitaires de Strasbourg; Nagoya City University Graduate School of Medical Sciences; Ehime University; University of Auckland; Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital; Carol Davila University of Medicine and Pharmacy; The Department of Cardiology at the Ljubljana University Medical Centre; Yonsei University College of Medicine; Department of Cardiovascular Sciences, University of Birmingham; King's College
Countries: United States; United States; Belgium; Belgium; France; France; Japan; Japan; New Zealand; Norway; Romania; Slovenia; South Korea; United Kingdom; United Kingdom
Enrollment: 400
Age range: 18 Years - None
Sex: ALL

Summary:
Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation. When heart failure and atrial fibrillation occur together, the risk of hospitalization and premature death increases significantly. However, there is a lack of reliable tools to assess how severely the heart is affected in these patients. This makes it difficult both to establish the correct diagnosis, tailor treatment, and predict who is at greatest risk of hospital admission or death from the disease.

One of the most important targets in heart failure is the filling pressure in the left ventricle. When this pressure is high, it means that the heart has difficulty receiving blood, leading to shortness of breath and fluid retention in the body. Today, filling pressure is usually estimated using ultrasound (echocardiography), but the available methods are primarily developed for patients without atrial fibrillation. In patients with both heart failure and atrial fibrillation, the measurements are so uncertain that they cannot be used as a reliable basis for clinical decision-making.

In this study, entitled Heart Failure combined with Atrial Fibrillation (HFcAF), the investigators will test new ultrasound methods that combine novel measures of cardiac chamber function with established techniques. Artificial intelligence will be used to identify the most useful combinations of parameters, select cardiac cycles that are best suited for analysis in atrial fibrillation, and automate and optimize the measurements. This approach may provide both more accurate and faster assessments, while also making the methods easier to implement in clinical practice. The aim is to improve the estimation of filling pressure so that it becomes more precise also in patients with atrial fibrillation. The investigators will then examine whether these improved methods can be used to predict which patients are at highest risk of hospitalization or death due to heart failure.

The study is designed as a prospective multicenter study, in which patients are recruited from several hospitals in different countries. This will make the results robust and generalizable to a wide range of patient populations. The investigators anticipate that the project will pave the way for better diagnostics and risk stratification in heart failure combined with atrial fibrillation and, in the longer term, contribute to improved guidelines and treatment for a large number of patients. If successful, the project will provide a new tool that can contribute to earlier and more targeted treatment, thereby improving quality of life and prognosis for a large group of patients.

Eligibility criteria:
Inclusion Criteria:

* Atrial fibrillation (paroxysmal, persistent, or permanent)
* Scheduled for RHC or LHC for clinical reasons
* Able to undergo echocardiography and invasive pressure measurement within 8 hours
* No cardiovascular medication changes between echo and catheterization
* Written informed consent provided

Exclusion Criteria:

* Mitral stenosis or mitral annular calcification causing severe functional stenosis
* Severe mitral or severe tricuspid regurgitation
* Prosthetic mitral valve
* Atrial fibrillation with rapid ventricular response \>120 bpm
* Suboptimal echocardiographic imaging
* Conditions rendering PCWP or LVEDP unreliable
* Pregnant women
* Complex congenital heart disease
* LV assist device and patients with severe non-cardiac disease with poor prognosis
* Cardiac transplant patients
* End-stage liver disease

Outcomes:
Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation; Imaging markers associated with mortality and heart-failure hospitalization in atrial fibrillation