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NCT07436299Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
21 Feb 2026
Start date
1 Sept 2026
Primary completion date
31 Jan 2028
Lead sponsor
Oslo University Hospital
NCT number
NCT07436299

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 1 Sept 2026 to the primary completion date, 31 Jan 2028
  • 15 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Conditions rendering PCWP or LVEDP unreliable
  • Complex congenital heart disease
  • LV assist device and patients with severe non-cardiac disease with poor prognosis
  • Cardiac transplant patients
  • End-stage liver disease

Other

  • 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
  • Pregnant women

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
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AalstBelgiumNot yet recruiting
Catholic University of Leuven
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LeuvenBelgiumNot yet recruiting
Laboratory Signal Processing and Image, Department of Cardiology
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RennesFranceNot yet recruiting
Service de Cardiologie, Hôpitaux Universitaires de Strasbourg
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StrasbourgFranceNot yet recruiting
Department of Cardiovascular Sciences, University of Birmingham
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BirminghamUnited KingdomNot yet recruiting
King's College
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LondonUnited KingdomNot yet recruiting
Nagoya City University Graduate School of Medical Sciences
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NagoyaJapanNot yet recruiting
Ehime University
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TōonJapanNot yet recruiting
Yonsei University College of Medicine
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SeoulSouth KoreaNot yet recruiting
Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital
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OsloNorwayRecruiting
University of Auckland
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AucklandNew ZealandNot yet recruiting
"Carol Davila" University of Medicine and Pharmacy
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BucharestRomaniaNot yet recruiting
The Department of Cardiology at the Ljubljana University Medical Centre
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LjubljanaSloveniaNot yet recruiting
Cleveland Clinic
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ClevelandUnited StatesNot yet recruiting
Methodist DeBakey Heart and Vascular Center
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HoustonUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.