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Clinical trialNCT07436299Not, yet, recruitingObservational

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

SponsorOslo University HospitalEnrollment400Atrial Fibrillation (AF)Heart Failure (HF)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Cardiovascular Center Aalst, Olv Clinic, Aalst, Belgium

    Aalst, Belgium

    Martin Penicka, MD, PhD
  • Catholic University of Leuven

    Leuven, Belgium

    Jens-Uwe Voigt, MD, PhD
France
  • Laboratory Signal Processing and Image, Department of Cardiology

    Rennes, France

    Erwan Donal, MD, PhD
  • Service de Cardiologie, Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

    Elena Galli, MD, PhD
Japan
  • Nagoya City University Graduate School of Medical Sciences

    Nagoya, Aichi-ken, Japan

    Nobuyuki Ohte, MD, PhD
  • Ehime University

    Tōon, Ehime, Japan

    Katsuji Inoue, MD, PhD
New Zealand
  • University of Auckland

    Auckland, Auckland, New Zealand

    Martyn Nash, MSc, PhD
Norway
  • Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital

    Oslo, Oslo, Norway

    Lars-Egil Reine Hammersboen, MD
Romania
  • Carol Davila University of Medicine and Pharmacy

    Bucharest, Romania

    Bogdan Popescu, MD, PhD
Slovenia
  • the Department of Cardiology at the Ljubljana University Medical Centre

    Ljubljana, Slovenia

    Marta Cvijic, MD, PhD
South Korea
  • Yonsei University College of Medicine

    Seoul, Seoul, South Korea

    Jong-Won Ha, MD, PhD
United Kingdom
  • Department of Cardiovascular Sciences, University of Birmingham

    Birmingham, United Kingdom

    Karina Bunting, PhD, MSc, BSc
  • King'S College

    London, United Kingdom

    Pablo Lamata, MSc, PhD
United States
  • Cleveland Clinic

    Cleveland, Ohio, United States

    Allan Klein, MD, PhD
  • Methodist Debakey Heart and Vascular Center

    Houston, Texas, United States

    Sherif Nagueh, MD, PhD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2026
Primary completion
31 Jan 2028
Completion
31 Dec 2029
Last update posted
5 Mar 2026
Registered enrollment
400
Registry id
NCT07436299

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.