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

Inclusion Criteria12

  • \. 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:
  • Obesity
  • Type 2 diabetes
  • Obstructive sleep apnea syndrome
  • Electrocardiogram showing left ventricular hypertrophy.
  • Left ventricular hypertrophy on echocardiogram.
  • Left atrial dilation.
  • Coronary artery disease
  • Chronic kidney disease
  • Heart failure with ejection fraction \> 50%
  • Alcohol intake
  • Frequent supraventricular ectopic beats

Exclusion Criteria1

  • \. 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.

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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