Novel Technologies for Heart Failure and Atrial Fibrillation

This study aims to improve how doctors measure the heart's pumping ability in people who have both heart failure and atrial fibrillation (an irregular heartbeat). Currently, it's hard to accurately assess how severe the heart is affected in these patients, which makes it difficult to diagnose and treat them effectively. Researchers will look at new ways to use echocardiograms (heart ultrasounds) and other information to better estimate the pressure inside the heart's main pumping chamber (left ventricle). The goal is to develop a reliable method to tell if this pressure is too high, which could help doctors provide better care and predict who might be at higher risk for hospital stays or other problems. About 400 participants will be included in this study.

Study design
This is an observational study involving about 400 participants. It will look at information from people who already have heart failure and atrial fibrillation.
What's involved
You would undergo an echocardiogram and an invasive heart pressure measurement (RHC or LHC) within 8 hours of each other, without changes to your heart medications in between.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 years after recruitment ends to observe outcomes related to mortality and heart-failure hospitalization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07436299

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

Recruiting
Not specifiedAges 18+Observational
Oslo University Hospital
~400 participants
Updated 2026-09-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation
Measured over • 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
+1 more outcome measured
Heart Failure (HF)
Atrial Fibrillation (AF)

NCT07436299

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

    Aalst, Belgiumstudy coordinator listed

    Not yet recruiting

  • Carol Davila University of Medicine and Pharmacy

    Bucharest, Romaniastudy coordinator listed

    Not yet recruiting

  • Catholic University of Leuven

    Leuven, Belgiumstudy coordinator listed

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Not yet recruiting

  • Department of Cardiovascular Sciences, University of Birmingham

    Birmingham, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital

    Oslo, Oslo, Norwaystudy coordinator listed

    Recruiting

  • Ehime University

    Tōon, Ehime, Japanstudy coordinator listed

    Not yet recruiting

  • King's College

    London, United Kingdomstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Otto Armin Smiseth, Professor, Medical Doctor · STUDY_CHAIR · Oslo University Hospital
  • Thor Edvardsen, Professor, Medical Doctor · STUDY_DIRECTOR · Oslo University Hospital
Lars-Egil Reine Hammersboen, Medical doctor
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation• 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.

  • Imaging markers associated with mortality and heart-failure hospitalization in atrial fibrillation• 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.