ClinicalTrials.gg
CompletedNCT07521293heart failureUpdated Apr 9, 2026

Intracranial Pressure and a Potential Vicious Circle of Atrial Fibrillation in HFpEF

An observational study in Heart Failure With Preserved Ejection Fraction (HFpEF), Atrial Fibrillation and Optic Nerve Sheath Diameter, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 60 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
309
Ages
60 Years to 78 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 55 studies in Atrial Fibrillation with a site in Turkey — 8 open to participants now, 9 under way, 2 of them phase 3. Atrial Fibrillation · Turkey.

Enrollment
14th of 25
309 · median 400
Started
2025
with 4 others
Observational
25 of 55
3 open now
Registered
51st of 55
by date
Lead sponsor
3 of 55
Ankara Ataturk Sanatorium Training and Research Hospital

Among the 55 studies in Atrial Fibrillation with a site in Turkey, this one is the 14th largest by enrollment of the 25 observational ones, is one of 5 that started in 2025, is one of 25 observational ones, and was the 51st registered.

By phase

55 studies; the count open now beside each. This study's row is marked.

Observationalthis study25 · 3 open
Phase 318 · 1 open
No phase10 · 3 open
Phase 42 · 1 open

By the year they started

First in 2003; this study’s year is marked. 5 started in 2025.

Size and results

Median enrollment 1,314 across the 30 interventional studies, 400 across the 25 observational. Of the 40 that completed or were terminated, 15 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 55 studies in Atrial Fibrillation with a site in Turkey, or all of them as a file.
02

Study summary

This study was designed to investigate predictors of atrial fibrillation (AF) in patients with heart failure with preserved ejection fraction (HFpEF), with a particular focus on the potential relationship between venous congestion and intracranial pressure dynamics. Among HFpEF patients, those with AF exhibited significantly higher right atrial pressure (RAP), larger right atrial area, higher CHA₂DS₂-VA scores, and increased optic nerve sheath diameter (ONSD), a noninvasive surrogate marker of intracranial pressure. In multivariable logistic regression analysis, increased ONSD, elevated RAP, larger right atrial area, and higher CHA₂DS₂-VA score remained independently associated with AF, suggesting that both systemic venous congestion and intracranial pressure-related mechanisms may contribute to AF susceptibility in this population. These findings support the hypothesis of a cardio-cerebral interaction in HFpEF, in which elevated right-sided filling pressures may impair cerebrospinal fluid drainage, increase intracranial pressure, and potentially promote AF through autonomic and hemodynamic pathways.

Read the detailed description

This study evaluates the association between atrial fibrillation (AF) and markers of systemic venous congestion and intracranial pressure in patients with heart failure with preserved ejection fraction (HFpEF). Using cranial MRI and echocardiographic assessment, optic nerve sheath diameter (ONSD), right atrial pressure (RAP), and atrial dimensions were analyzed as potential correlates of AF. Multivariable analysis demonstrated that increased ONSD, elevated RAP, larger right atrial area, and higher CHA₂DS₂-VA score were independently associated with AF. The findings support a potential pathophysiological link between venous congestion, intracranial pressure dynamics, and AF susceptibility in HFpEF, suggesting a possible cardio-cerebral interaction that may contribute to arrhythmogenesis and stroke risk.

03

Conditions studied

  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Atrial Fibrillation
  • Optic Nerve Sheath Diameter
  • Intracranial Pressure
  • Venous Congestion

Keywords

  • HFpEF;
  • Atrial fibrillation
  • Venous congestion
  • Optic nerve sheath diameter
  • Cranial MRI
  • Echocardiography
  • Intracranial pressure
04

Who can participate

Ages eligible
60 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A total of 309 subjects aged approximately 60-78 years with available cranial MRI data were enrolled, including a control group (n = 106), HFpEF patients in sinus rhythm (n = 111), and HFpEF patients with atrial fibrillation (n = 92).

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.

Inclusion criteria

Adults aged approximately 60-78 years with available cranial MRI , HFpEF patients in sinus rhythm, HFpEF patients with atrial fibrillation No HFpEF patients(control) -

Exclusion criteria

Exclusion Criteria:

Patients with heart failure and reduced (EF \<50%), known intracranial hypertension, optic nerve or other neurological disorders, , goiter, liver cirrhosis, renal failure, severe valvular heart disease, congenital heart disease, and advanced diabetes mellitus requiring insulin therapy

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Terms in these criteria, in plain language(3)

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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
309 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Individuals without HFpEF or atrial fibrillation were used as the reference group.

    Diagnostic Test: Echocardiography

  • group2

    HFpEF With Sinus Rhythm

    Diagnostic Test: Echocardiography

  • group 3

    HFpEF With Atrial Fibrillation

    Diagnostic Test: Echocardiography

Interventions

  • Diagnostic testEchocardiography

    Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.

06

What researchers measure

Primary outcomes

  1. Atrial fibrillation status (AF vs sinus rhythm) in HFpEF patients

    The primary analysis evaluates the association of ONSD, RAP, and the right atrial area with AF status.

    Time frame: Baseline

  2. Presence of atrial fibrillation in patients with HFpEF

    The rhythm status was measured by electrocardiography and documented. The primary analysis evaluates the association of ONSD, RAP, and right atrial area with AF status.

    Time frame: At baseline (cross-sectional assessment)

07

Study locations

1 site
  • Ankara Ataturk Strh
    Ankara, Ankara 06310, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data will be available upon reasonable request for academic research purposes, subject to ethics committee approval and data protection policies.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: Beginning 6 months after publication and ending 5 years after publication

Access criteria: Qualified researchers with a scientifically sound proposal may access de-identified IPD, the study protocol, SAP, and analytic code upon written request to the corresponding author, subject to ethics approval and data use agreement.

Data sharing details ↗ · sanatoryumdh.saglik.gov.tr

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Mar 2026, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2026
First posted
Apr 9, 2026
StartActual
Oct 14, 2025
Primary completionActual
Mar 20, 2026
CompletionActual
Mar 20, 2026
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07521293
Lead sponsor
Ankara Ataturk Sanatorium Training and Research Hospital
Responsible party
Şahbender Koç (cardıologıst md, Ankara Ataturk Sanatorium Training and Research Hospital) — Principal investigator
First posted
Apr 9, 2026
Start date
Oct 14, 2025
Primary completion
Mar 20, 2026
Completion
Mar 20, 2026
Last update
Apr 9, 2026

Study contacts

şahbender koç, MD
study chair · AnkaraAtatürk STRH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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