Heart Failure With Preserved Ejection Fraction (HFpEF)heart failureNCT07521293
Intracranial Pressure and a Potential Vicious Circle of Atrial Fibrillation in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction (HFpEF) and Atrial Fibrillation, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF), Atrial Fibrillation, Optic Nerve Sheath Diameter
- What is being tested?
- Echocardiography
- How many people
- 309 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2025to 20 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Adults aged approximately 60-78 years with available cranial MRI , HFpEF patients in sinus rhythm, HFpEF patients with atrial fibrillation No HFpEF patients(control) -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF), Atrial Fibrillation, Optic Nerve Sheath Diameter, Intracranial Pressure, Venous Congestion
- Being tested
- Echocardiography
- Keywords
- HFpEF;, Atrial fibrillation, Venous congestion, Optic nerve sheath diameter, Cranial MRI, Echocardiography, Intracranial pressure
- Medical subject headings
- Atrial Fibrillation, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Individuals without HFpEF or atrial fibrillation were used as the reference group. Receives: Diagnostic Test: Echocardiography | |
| group2 | HFpEF With Sinus Rhythm Receives: Diagnostic Test: Echocardiography | |
| group 3 | HFpEF With Atrial Fibrillation Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start14 Oct 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- şahbender koç, MD, Study chair, AnkaraAtatürk STRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521293
- Sponsor's protocol ID
- 2024-BÇEK/385
- Other IDs
- 2024-BÇEK/385
- Acronym
- heart failure
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.