RecruitingNCT07058831

Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

Home Monitoring for the Detection of Subclinical Atrial Fibrillation in Hypertensive Patients at Moderate to High Risk of Developing Arrhythmia. BP/AF MODE Study.


Sponsor

Cardiovascular Research Center Rosario British Sanatorium

Enrollment

499 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is checking whether wearable heart monitors can detect an irregular heart rhythm called atrial fibrillation (AFib) in older patients with high blood pressure, before they experience any symptoms. Early detection may help prevent strokes and other serious complications. **You may be eligible if...** - You have high blood pressure (hypertension) and are over 75 years old, OR - You are between 65 and 75 years old with high blood pressure AND at least one additional risk factor such as obesity, type 2 diabetes, sleep apnea, or certain changes on your ECG - You do not already have a known diagnosis of AFib **You may NOT be eligible if...** - You have already been diagnosed with atrial fibrillation - You already have a pacemaker or implanted heart device that monitors rhythm - You have conditions that make wearing a monitor impractical - You have a very short life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHome ECG monitoring

The 30-second home ECG tracings will be obtained using the Omron Complete Hem-7530 T ECG device (Omron Healthcare Co., Ltd., Japan). The connection and smartphone app download will be available from Omron Connect free of charge on the Google Play Store: https://play.google.com/store/apps/details?id=jp.co.omron.healthcare.omron\_connect\&hl=es\_419\&pli=1 and on the iOS App Store: https://apps.apple.com/mx/app/omron-connect/id1003177043. Two duplicate ECG recordings will be required daily: the first in the morning before breakfast and taking the prescribed medication, and another in the evening before dinner and taking the afternoon/evening medication. Additional ECG recordings will be required if the patient experiences any symptoms.


Locations(1)

British Sanatorium Cardiovascular Research Center

Rosario, Santa Fe Province, Argentina

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NCT07058831


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