Clinical Trials Directory

Trials / Completed

CompletedNCT07521293

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
309 (actual)
Sponsor
Ankara Ataturk Sanatorium Training and Research Hospital · Other Government
Sex
All
Age
60 Years – 78 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2025-10-14
Primary completion
2026-03-20
Completion
2026-03-20
First posted
2026-04-09
Last updated
2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07521293. Inclusion in this directory is not an endorsement.