About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Obesity
Type 2 diabetes
Obstructive sleep apnea syndrome
Electrocardiogram showing left ventricular hypertrophy.
Disqualifiers
1. History of any type of atrial fibrillation. 2. Receiving pharmacological treatments with potential impact on heart rhythm. 3. History of potentially malignant ventricular arrhythmias. 4. Uncontrolled hypothyroidism or hyperthyroidism. 5. Significant chronic obstructive pulmonary disease.
Trial population
Hypertensive patients older than 75 years or between 65 to 75 years with moderate-high risk developing atrial fibrilation by HARMS2-AF score \> 5 or a modified Taiwan AF score \> 4
Trial design
Cohort
Prospective
Treatments tested in this trial
Home ECG monitoring
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
new atrial fibrillation
The MODO PA/AF study will seek to determine the number of hypertensive patients who develop new atrial fibrillation, whether symptomatic or asymptomatic. As well as building an algorithm with artificial intelligence to determine the risk of suffering from a new atrial fibrillation
The absolute numbers of patients with new atrial fibrillation
The primary outcome measure of MODE BP/AF study is to detect subclinical atrial fibrillation. A central core lab is in charge of reading the ECG strips and reporting the research team new atrial fibrillation.
The percentage of patients with new atrial fibrillation
The primary outcome measure of MODE BP/AF study is to detect subclinical atrial fibrillation. A central core lab is in charge of reading the ECG strips and reporting the research team new atrial fibrillation.
Sponsors and contacts
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