Intracranial Pressure and a Potential Vicious Circle of Atrial Fibrillation in HFpEF (heart failure)

April 3, 2026 updated by: Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital

INTRACRANIAL PRESSURE AND A POTENTIAL VICIOUS CIRCLE OF ATRIAL FIBRILLATION IN HFPEF

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06310
        • Ankara Ataturk Strh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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).

Description

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:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Individuals without HFpEF or atrial fibrillation were used as the reference group.
Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
group2
HFpEF With Sinus Rhythm
Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
group 3
HFpEF With Atrial Fibrillation
Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation status (AF vs sinus rhythm) in HFpEF patients
Time Frame: Baseline
The primary analysis evaluates the association of ONSD, RAP, and the right atrial area with AF status.
Baseline
Presence of atrial fibrillation in patients with HFpEF
Time Frame: At baseline (cross-sectional assessment)
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.
At baseline (cross-sectional assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: şahbender koç, MD, AnkaraAtatürk STRH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2025

Primary Completion (Actual)

March 20, 2026

Study Completion (Actual)

March 20, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 6 months after publication and ending 5 years after publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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