Clinical Trial

Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

Recruiting
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Record status
This record was last updated July 10, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Atrial fibrillation is a highly prevalent and incidental arrhythmia, often asymptomatic, and frequently detected incidentally or in association with a stroke. Subclinical atrial fibrillation increases cardioembolic risk, highlighting the need for timely diagnosis. New wireless devices capable of recording heart rhythm, combined with innovative artificial intelligence tools, could be useful in the prediction and detection of this arrhythmia. Objective: to determine the usefulness of home blood pressure and heart rhythm monitoring strategy in the detection of subclinical atrial fibrillation. Methods: observational, cohort, prospective, multicenter study involving 25 researchers from six Latin American countries. Home blood pressure monitoring and single-lead electrocardiogram recording were performed in a population at moderate to high risk of developing atrial fibrillation. A minimum of twenty 30-second electrocardiographic and blood pressure recordings over 7 days using an Omron Complete Hem-7530 T ECG device will be uploaded from a mobile phone app and then sent to a database for analysis. Conclusions: the results of this study can provide a simple and accessible home monitoring system for detecting subclinical atrial fibrillation and for optimizing the predictive capacity of arrhythmia risk scores through deep learning.
Trial Details
NCT Number NCT07058831
Lead Sponsor Cardiovascular Research Center Rosario British Sanatorium
Conditions Asymptomatic Atrial Fibrillation
Enrollment 499 participants
Start Date 2025-03-01
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-10