The HCBx permanent AF substudy: The contribution of AF related hemodynamics to structural brain abnormalities and cognitive function decline

Recruiting

• Conditions: a-fib; atrial fibrillation; cognitive impairment; memory disorder; 10007521; 10042258; 10009841

• Registration Number: NL-OMON54040
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

Age 60-80 years (stratified in 60-65, 66-70, 71-75, 76-80 years, minimal 20
patients per group)
Knowledge of Dutch language
Permanent AF
Able to undergo MRI
Able to undergo cognitive testing
Mandatory use of coagulation
Gender stratification 50/50 (bandwidth 40%-60%)

Exclusion Criteria

A clinical diagnosis of dementia is a contra-indication for participation in
this study
Other neurological or psychiatric diagnosis that affects cognitive performance
or testing, such as severe traumatic brain injury or substance abuse
A history of stroke
A pacemaker/ICD in situ >5% ventricular pacing
Severly impaired LVEF
PVI or CABG in the past three months

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cognitive functioning at baseline and cognitive decline at two year follow up<br /><br>measured with neuropsychological assessment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Heart rate variability and irregularity<br /><br>Peripheral blood pressure variation<br /><br>Structural brain abnormalities<br /><br>Risk factors </p><br>