- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521293
Intracranial Pressure and a Potential Vicious Circle of Atrial Fibrillation in HFpEF (heart failure)
INTRACRANIAL PRESSURE AND A POTENTIAL VICIOUS CIRCLE OF ATRIAL FIBRILLATION IN HFPEF
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06310
- Ankara Ataturk Strh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Individuals without HFpEF or atrial fibrillation were used as the reference group.
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Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
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group2
HFpEF With Sinus Rhythm
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Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
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group 3
HFpEF With Atrial Fibrillation
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Standard transthoracic echocardiography, including EF, E/e', TRV, atrial areas, SPAP, and estimated right atrial pressure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Atrial fibrillation status (AF vs sinus rhythm) in HFpEF patients
Time Frame: Baseline
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The primary analysis evaluates the association of ONSD, RAP, and the right atrial area with AF status.
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Baseline
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Presence of atrial fibrillation in patients with HFpEF
Time Frame: At baseline (cross-sectional assessment)
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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.
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At baseline (cross-sectional assessment)
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Collaborators and Investigators
Investigators
- Study Chair: şahbender koç, MD, AnkaraAtatürk STRH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Pathological Conditions, Signs and Symptoms
- Atrial Fibrillation
- Hyperemia
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Cardiac Imaging Techniques
- Ultrasonography
- Echocardiography
Other Study ID Numbers
- 2024-BÇEK/385 (Other Identifier: Ankara Ataturk STRH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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