An observational study in Heart Failure (HF) and Atrial Fibrillation (AF), sponsored by Oslo University Hospital. Recruiting at 15 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Oslo University Hospital · Observational
Among 11 studies in Heart Failure by Oslo University Hospital — 4 open to participants now, 4 under way, none of them phase 3. Heart Failure · Oslo University Hospital.
Among the 11 studies in Heart Failure by Oslo University Hospital, this one is the only one that started in 2026, is one of 4 observational ones, and was the 11th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →4 of the 11 studies in Heart Failure by Oslo University Hospital are open now, in 10 countries. Recruiting first, the newest first:
Oslo University Hospital · Sites in Norway
Oslo University Hospital · Sites in Norway
Oslo University Hospital · Sites in Norway
By country, each count listing its studies:
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 400 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Median enrollment 75 across the 7 interventional studies, 200 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Heart Failure by Oslo University Hospital, from their registry updates:
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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 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
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
Patients with atrial fibrillation undergoing clinically indicated right or left heart catheterization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic accuracy of a non-invasive algorithm for classification of left ventricular filling pressure in atrial fibrillation
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.
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
Imaging markers associated with mortality and heart-failure hospitalization in atrial fibrillation
To identify prognostic imaging markers associated with mortality and heart-failure hospitalization over a 3-year follow-up period.
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
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available from February 2026 and will remain available for 3 years.
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.
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 16 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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