NCT07436299 · Oslo University Hospital
Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation
(HFcAF)
What this study is about
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.
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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.
Primary outcome measures
Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation
Time frame: • Start recruitment: February 2026 • End recruitment: January 2028 • Follow-up: 3 years • Data analysis: Ferbuary 2026 - December 2028. Outcome analysis will be extended to 3 years of follow-up. • Manuscript preparation: December 2028 - December 2029
Main aim of the study is to develop and validate a clinically applicable algorithm combining echocardiographic and clinical parameters to differentiate normal from elevated LV filling pressure in AF with ≥80% diagnostic accuracy. Left venticular filling pressures will be measured during right- or left-sided heart catehterization and left ventricular filling pressure \>15 mmHg will be considered elevated.
Imaging markers associated with mortality and heart-failure hospitalization in atrial fibrillation
Time frame: • Start recruitment: February 2026 • End recruitment: January 2028 • Follow-up: 3 years • Data analysis: Ferbuary 2026 - December 2028. Outcome analysis will be extended to 3 years of follow-up. • Manuscript preparation: December 2028 - December 2029
To identify prognostic imaging markers associated with mortality and heart-failure hospitalization over a 3-year follow-up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cleveland, Ohio
- Houston, Texas
Collaborators
The National Association for Public Health, Norway
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Data: ClinicalTrials.gov · synced Sep 10, 2026 · Source of record for eligibility and locations