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

Study acronym: HFcAF
StatusRecruiting
PhaseNot specified
Started2026-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
notable
Study Status, Contacts/Locations v3
Recruitment opened
Start date2026-02→2026-09
Study sitesdetails revised at 15 of 15 sites
2026-03-03
minor
Study Identification, Study Status v2
Study title-8 characters
[...] Pressure in Heart Failure Combined With Atrial Fibrillation (HFcAF)
2026-03-02
minor
Study Identification, Study Status, Study Description, Outcome Measures v1
Study description+453 characters
Study Design: This is a prospective, multicentremulticenter study of atrial fibrillation (AF) patients referred for right or left heart catheterization (RHC/LHC). The primary objective will be to develop and validate [...] normal from elevated left ventricular (LV) filling pressure (LVFP) in AF with ≥80% diagnostic accuracy. Secondary objectives wi [...] and heart-failure outcomes over a 3-year follow-up period. LV filling pressure (LVFP) will be measured as PCWP during right heart catheterization (RHC) and as LV end-diastolic pressure (LVEDP) during left heart catheterization (LHC). In cases studiesstudi [...] [...]
Study title-33 characters
[...] e in Heart Failure Combined With Atrial Fibrillation (HFcAF): A Prospective Multicenter Study
2026-02-21
minor
Original filing
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.
Trial Details
NCT Number NCT07436299
Lead Sponsor Oslo University Hospital
Collaborators: The National Association for Public Health, Norway
Conditions Heart Failure (HF), Atrial Fibrillation (AF)
Enrollment 400 participants
Start Date 2026-09
Primary Completion 2028-01 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-10