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

NCT07521293 | Completed

• 1 other identifier: 2024-BÇEK/385
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  At baseline (cross-sectional assessment)

Study Arms (3)

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

Echocardiography DIAGNOSTIC_TEST

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

Group 1; group 3; group2

Eligibility Criteria

• Age: 60 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Ataturk Strh

Ankara, Ankara, 06310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hyperemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• şahbender koç, MD

  AnkaraAtatürk STRH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cardıologıst md

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: October 14, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

TU (1)