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OpenTrials
Completed

NCT Number: NCT07521293

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Echocardiography

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Acronym: heart failure

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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