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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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:

‣ 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

Locations
Other Locations
Argentina
British Sanatorium Cardiovascular Research Center
RECRUITING
Rosario
Contact Information
Primary
Daniel L Piskorz, MD
daniel.l.piskorz@gmail.com
5493415416828
Backup
Ricardo López Santi, MD
lopezsan@live.com.ar
54 92215081467
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 499
Treatments
Hypertensive patients older 75 or Hypertensive patients between 65 and 75 at moderate-high risk AF
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.
Related Therapeutic Areas
Sponsors
Leads: Cardiovascular Research Center Rosario British Sanatorium

This content was sourced from clinicaltrials.gov