Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorCardiovascular Research Center Rosario British Sanatorium

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Home ECG monitoring

    Device

    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.

Treatment groups

499 Participants
are divided into 1 treatment group
Group A: Hypertensive patients older 75 or Hypertensive patients between 65 and 75 at moderate-high risk AF1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
one year
2

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.

Time frame
one year
3

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.

Time frame
one year

Secondary outcomes

Other outcomes

Sponsors and contacts

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