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Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

ClinicalTrials.gov IDNCT07058831

PhaseNot Applicable

Enrollment499

SponsorCardiovascular Research Center Rosario British Sanatorium

Age65 Years and older

SexALL

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Conditions studied

Asymptomatic Atrial Fibrillation

About this study

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.

Interventions

Device: Home 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.

Primary outcomes

new atrial fibrillation (one year)
The absolute numbers of patients with new atrial fibrillation (one year)
The percentage of patients with new atrial fibrillation (one year)

Eligibility information

Inclusion Criteria: * 1\. Hypertensive patients of both sexes over 75 years of age. 2. Hypertensive patients between 65 and 75 years of age are associated with one of the following risk factors: 1. Obesity 2. Type 2 diabetes 3. Obstructive sleep apnea syndrome 4. Electrocardiogram showing left ventricular hypertrophy. 5. Left ventricular hypertrophy on echocardiogram. 6. Left atrial dilation. 7. Coronary artery disease 8. Chronic kidney disease 9. Heart failure with ejection fraction \> 50% 10. Alcohol intake 11. Frequent supraventricular ectopic beats Exclusion Criteria: * 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.

Study locations

British Sanatorium Cardiovascular Research Center, Rosario, Santa Fe Province 2000 Argentina

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.