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

March 3, 2026 updated by: Lars-Egil Hammersbøen, Oslo University Hospital

Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation: A Prospective Multicenter Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Design:

This is a prospective, multicenter study of atrial fibrillation (AF) patients referred for right or left heart catheterization (RHC/LHC). The primary objective will be to develop and validate a clinically applicable algorithm combining echocardiographic and clinical parameters to differentiate normal from elevated left ventricular (LV) filling pressure (LVFP) in AF with ≥80% diagnostic accuracy. Secondary objectives will be to identify imaging predictors of abnormal pulmonary capillary wedge pressure (PCWP) elevation during exercise and to identify prognostic imaging markers associated with mortality and heart-failure outcomes over a 3-year follow-up period.

LVFP will be measured as PCWP during RHC and as LV end-diastolic pressure (LVEDP) during LHC. In cases studied during left atrial (LA) interventions, LA mean pressure will be used as a measure of LVFP. Echocardiography will be performed during, immediately before, or immediately after catheterization (≤8 hours separation, without cardiovascular medication changes). A dedicated exercise substudy will investigate imaging predictors of abnormal PCWP rise during exertion.

Recruitment of at least 400 patients is considered feasible based on experience from a previous international multicenter AF study. Patients will be recruited from 15 centers in the USA, Europe, Asia, and New Zealand over a period of 1.5 to 2 years.

Data collection:

A 12-lead electrocardiogram (ECG) and standard clinical data, including cuff blood pressure and standard blood tests with NT-proBNP, will be recorded.

Echocardiographic Imaging:

Echocardiographic measurements will be performed according to most recent American Society of Echocardiography / European Association of Cardiovascular Imaging guidelines. In addition, LA and right atrial (RA) strains will be measured. Echocardiographic recordings will be obtained by experienced investigators without knowledge of the invasive data. A core lab for echo analysis will be established. A minimum of 10 consecutive heartbeats will be recorded. Echo will be performed either simultaneously or within 8 hours of hemodynamic assessment. Equipment from different vendors will be used. Three-dimensional echocardiography will be used in selected patients.

Key Echocardiographic Views and Measurements

  • Apical 4-chamber LV-focused: mitral inflow, tissue Doppler early diastolic velocity (e') (septal, lateral, average), systolic velocity (s'), isovolumetric relaxation time, LV global longitudinal strain (GLS), LV volumes and ejection fraction, LV mass
  • Apical 4-chamber LA-focused: pulmonary vein Doppler (S and D velocities and their velocity-time integrals), LA strain, LA volumes
  • Apical 5-chamber: aortic valve continuous-wave (CW) Doppler
  • Apical 2- and 3-chamber: LV GLS, focused LV/LA imaging
  • Right ventricular / pulmonary artery evaluation: tricuspid regurgitation velocity, right ventricular outflow tract (RVOT) pulsed-wave Doppler, RVOT acceleration time
  • Subcostal inferior vena cava (IVC) view: IVC diameter and collapsibility.
  • RA-focused view: RA reservoir strain

Cardiac Catheterization:

LVFP >15 mmHg will be considered elevated. LVFP will be averaged over 10 beats during end-expiration, using an index beat approach for selection of heart cycles.

Bicycle ergometer in supine position with simultaneous RHC will be performed in patients scheduled for this procedure as part of a diagnostic work-up and will be performed according to current clinical routine. This includes pressure measurements and focused echocardiographic study at rest and at peak exercise. The rate of pedaling will be 60 rotations per minute, and the workload will increase gradually to a moderate level.

Outcome Data:

All-cause mortality and heart failure hospitalizations will be the primary clinical outcomes. Outcome analysis will be extended to 3 years of follow-up.

Data Management and Analysis:

All imaging and invasive pressure measurements will be analyzed with investigators blinded to the corresponding data. Echocardiography will be reviewed centrally at the Echo Core Laboratory. Statistical analyses will include descriptive statistics, logistic regression, receiver operating characteristic curve analysis, and supervised machine-learning methods to derive a diagnostic algorithm. A two-sided P value <0.05 will be considered statistically significant.

Study Flowchart:

1. Screening → 2. Consent → 3. Clinical assessment & ECG → 4. Echocardiography → 5. RHC/LHC (± exercise) → 6. Data transfer to core labs → 7. Follow-up → 8. Analysis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
        • Principal Investigator:
          • Martin Penicka, MD, PhD
        • Contact:
        • Contact:
      • Leuven, Belgium, 3000
        • Catholic University of Leuven
        • Contact:
        • Principal Investigator:
          • Jens-Uwe Voigt, MD, PhD
  • France
      • Rennes, France, 35033
        • Laboratory Signal Processing and Image, Department of Cardiology
        • Principal Investigator:
          • Erwan Donal, MD, PhD
        • Contact:
      • Strasbourg, France, 67091
        • Service de Cardiologie, Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Elena Galli, MD, PhD
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8601
        • Nagoya City University Graduate School of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Nobuyuki Ohte, MD, PhD
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University
        • Contact:
        • Principal Investigator:
          • Katsuji Inoue, MD, PhD
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1010
        • University of Auckland
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martyn Nash, MSc, PhD
  • Norway
    • Oslo County
      • Oslo, Oslo County, Norway, 0424
        • Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lars-Egil Reine Hammersboen, MD
  • Romania
      • Bucharest, Romania, 020021
        • Carol Davila University of Medicine and Pharmacy
        • Contact:
        • Principal Investigator:
          • Bogdan Popescu, MD, PhD
  • Slovenia
      • Ljubljana, Slovenia, SI-1525
        • The Department of Cardiology at the Ljubljana University Medical Centre
        • Contact:
        • Principal Investigator:
          • Marta Cvijic, MD, PhD
  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03722
        • Yonsei University College of Medicine
        • Contact:
          • Jong-Won Ha, MD, PhD
          • Phone Number: +82-33-741-0211
          • Email: JWHA@yuhs.ac
        • Principal Investigator:
          • Jong-Won Ha, MD, PhD
  • United Kingdom
      • Birmingham, United Kingdom
        • Department of Cardiovascular Sciences, University of Birmingham
        • Contact:
        • Principal Investigator:
          • Karina Bunting, PhD, MSc, BSc
      • London, United Kingdom, WC2R2LS
        • King's College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Lamata, MSc, PhD
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
        • Contact:
          • Tom Wang, MD, PhD
          • Phone Number: +1 440-823-2688
          • Email: WANGT2@ccf.org
        • Contact:
        • Principal Investigator:
          • Allan Klein, MD, PhD
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation undergoing clinically indicated right or left heart catheterization.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
• 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
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.
• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The National Association for Public Health, Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Otto Armin Smiseth, Professor, Medical Doctor, Oslo University Hospital
  • Study Director: Thor Edvardsen, Professor, Medical Doctor, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 964539
  • 52438 (Other Grant/Funding Number: Nasjonalforeningen for folkehelsen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available from February 2026 and will remain available for 3 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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