NCT07436299 Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation
| NCT ID | NCT07436299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Heart Failure (HF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-09 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-09 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Otto Armin Smiseth, Professor, Medical Doctor
STUDY CHAIR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT07436299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure (HF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436299 currently recruiting?
Yes, NCT07436299 is actively recruiting participants. Contact the research team at lerhammersboen@gmail.com for enrollment information.
Where is the NCT07436299 trial being conducted?
This trial is being conducted at Cleveland, United States, Houston, United States, Aalst, Belgium, Leuven, Belgium and 11 additional locations.
Who is sponsoring the NCT07436299 clinical trial?
NCT07436299 is sponsored by Oslo University Hospital. The principal investigator is Otto Armin Smiseth, Professor, Medical Doctor at Oslo University Hospital. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.