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
- Are there results?
- None posted in the registry
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRACRANIAL PRESSURE AND A POTENTIAL VICIOUS CIRCLE OF ATRIAL FIBRILLATION IN HFPEF
- ClinicalTrials.gov ID
- NCT07521293
- Acronym / sponsor ID
- heart failure / 2024-BÇEK/385
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF), Atrial Fibrillation, Optic Nerve Sheath Diameter, Intracranial Pressure, Venous Congestion
- Keywords
- HFpEF;, Atrial fibrillation, Venous congestion, Optic nerve sheath diameter, Cranial MRI, Echocardiography, Intracranial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: EchocardiographyIndividuals without HFpEF or atrial fibrillation were used as the reference group. |
| group2 | – | Diagnostic Test: EchocardiographyHFpEF With Sinus Rhythm |
| group 3 | – | Diagnostic Test: EchocardiographyHFpEF With Atrial Fibrillation |
Who may qualify
- Ages
- 60 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- Adults aged approximately 60-78 years with available cranial MRI , HFpEF patients in sinus rhythm, HFpEF patients with atrial fibrillation No HFpEF patients(control) -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyStandard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure. | Diagnostic test | Group 1, group 3, group2 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
şahbender koç, MD study chair
AnkaraAtatürk STRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation status (AF vs sinus rhythm) in HFpEF patients (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.