Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation
HFcAF
2 other identifiers
observational
400
10 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 21, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
March 5, 2026
March 1, 2026
1.9 years
February 21, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation
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.
• 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
Imaging markers associated with mortality and heart-failure hospitalization in atrial fibrillation
To identify prognostic imaging markers associated with mortality and heart-failure hospitalization over a 3-year follow-up period.
• 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
Study Arms (1)
Patients with atrial fibrillation referred for right- or left-heart catheterization
We will recruit patients \>18 years with established or suspected heart failure who have atrial fibrillation and are referred to a diagnostic right- or left-sided heart catheterization or interventional procedures via the left atrium. Balanced numbers with normal and reduced left venticular ejection fraction, balanced representation of sexes, of short (\<1year) and long-lasting duration of atrial fibrillation will be attempted.
Eligibility Criteria
Patients with atrial fibrillation undergoing clinically indicated right or left heart catheterization.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Methodist DeBakey Heart and Vascular Center
Houston, Texas, 77030, United States
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
Aalst, 9300, Belgium
Catholic University of Leuven
Leuven, 3000, Belgium
Laboratory Signal Processing and Image, Department of Cardiology
Rennes, 35033, France
Service de Cardiologie, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi-ken, 467-8601, Japan
Ehime University
Tōon, Ehime, 791-0295, Japan
University of Auckland
Auckland, Auckland, 1010, New Zealand
Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital
Oslo, Oslo County, 0424, Norway
Carol Davila University of Medicine and Pharmacy
Bucharest, 020021, Romania
The Department of Cardiology at the Ljubljana University Medical Centre
Ljubljana, SI-1525, Slovenia
Yonsei University College of Medicine
Seoul, Seoul, 03722, South Korea
Department of Cardiovascular Sciences, University of Birmingham
Birmingham, United Kingdom
King's College
London, WC2R2LS, United Kingdom
Related Publications (5)
Nagueh SF, Sanborn DY, Oh JK, Anderson B, Billick K, Derumeaux G, Klein A, Koulogiannis K, Mitchell C, Shah A, Sharma K, Smiseth OA, Tsang TSM. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography and for Heart Failure With Preserved Ejection Fraction Diagnosis: An Update From the American Society of Echocardiography. J Am Soc Echocardiogr. 2025 Jul;38(7):537-569. doi: 10.1016/j.echo.2025.03.011.
PMID: 40617625BACKGROUNDKhan FH, Zhao D, Ha JW, Nagueh SF, Voigt JU, Klein AL, Gude E, Broch K, Chan N, Quill GM, Doughty RN, Young A, Seo JW, Garcia-Izquierdo E, Monivas-Palomero V, Mingo-Santos S, Wang TKM, Bezy S, Ohte N, Skulstad H, Beladan CC, Popescu BA, Kikuchi S, Panis V, Donal E, Remme EW, Nash MP, Smiseth OA. Evaluation of left ventricular filling pressure by echocardiography in patients with atrial fibrillation. Echo Res Pract. 2024 Jun 3;11(1):14. doi: 10.1186/s44156-024-00048-x.
PMID: 38825684BACKGROUNDGomez-Outes A, Lagunar-Ruiz J, Terleira-Fernandez AI, Calvo-Rojas G, Suarez-Gea ML, Vargas-Castrillon E. Causes of Death in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2016 Dec 13;68(23):2508-2521. doi: 10.1016/j.jacc.2016.09.944.
PMID: 27931607BACKGROUNDZafrir B, Lund LH, Laroche C, Ruschitzka F, Crespo-Leiro MG, Coats AJS, Anker SD, Filippatos G, Seferovic PM, Maggioni AP, De Mora Martin M, Polonski L, Silva-Cardoso J, Amir O; ESC-HFA HF Long-Term Registry Investigators. Prognostic implications of atrial fibrillation in heart failure with reduced, mid-range, and preserved ejection fraction: a report from 14 964 patients in the European Society of Cardiology Heart Failure Long-Term Registry. Eur Heart J. 2018 Dec 21;39(48):4277-4284. doi: 10.1093/eurheartj/ehy626.
PMID: 30325423BACKGROUNDJones NR, Smith M, Yang Y, Hobbs FDR, Taylor CJ. Trends in mortality in people with heart failure and atrial fibrillation: a population-based cohort study. Lancet Healthy Longev. 2025 Aug;6(8):100734. doi: 10.1016/j.lanhl.2025.100734. Epub 2025 Aug 13.
PMID: 40818479BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Otto Armin Smiseth, Professor, Medical Doctor
Oslo University Hospital
- STUDY DIRECTOR
Thor Edvardsen, Professor, Medical Doctor
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Researcher and Medical Doctor
Study Record Dates
First Submitted
February 21, 2026
First Posted
February 27, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will become available from February 2026 and will remain available for 3 years.
- Access Criteria
- Local Primary Investigator, administrative leader and the research director at each center will access the IPD and supporting information. Data will be provided in a de-identified format in accordance with General Data Protection Regulation and institutional regulations.
De-identified individual participant data (IPD) underlying the results reported in this study, including the data dictionary, will be made available to qualified researchers upon reasonable request. Supporting documents, including the study protocol, statistical analysis plan, and analytic code, will also be available.