Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

NCT07058831 | Recruiting DMC FDA Device

• 1 other identifier: PA/AF Mode
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asymptomatic Atrial Fibrillation

Keywords

hypertension; atrial fibrillation; home monitoring; artificial intelligence

Outcome Measures

Primary Outcomes (3)

• 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

  one year

• 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.

  one year

• 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.

  one year

Study Arms (1)

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.

Device: Home ECG monitoring

Interventions

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.

Hypertensive patients older 75 or Hypertensive patients between 65 and 75 at moderate-high risk AF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Cardiovascular Research Center Rosario British Sanatorium: lead

Study Sites (1)

British Sanatorium Cardiovascular Research Center

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Related Publications (1)

• Piskorz D, Lopez-Santi R, Piskorz G, Perez M, Juarez-Lloclla J, Palomo-Pinon S, Anchique-Santos C, Cardenas-Castellanos J, Nuriulu P, De Las Salas-Perez H, Ruise M, Brondello S, Del Sueldo M, Duarte-Vera Y, Munera-Echeverri A, Celis D, Miranda G, Norabuena-Rossel L, Marino M, Alvarez-Lopez H, Cedeno-Zambrano MJ, Rocha-Enciso L, Galvan-Oseguera H, Ramos-Carrillo F, Penaherrera-Oviedo M. Home monitoring for the detection of atrial fibrillation in hypertensive patients. BP/AF MODE study. Arch Cardiol Mex. 2026 Jan 12. doi: 10.24875/ACM.25000149. Online ahead of print.

  PMID: 41525689 DERIVED

Related Links

• research center webpage. You are reporting that the URL does not appear to link to a functioning web page. But the URL is wotking

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel L Piskorz, MD

  British Sanatorium Cardiovascular Research Center

  STUDY CHAIR

Central Study Contacts

Daniel L Piskorz, MD

CONTACT

5493415416828; daniel.l.piskorz@gmail.com

Ricardo López Santi, MD

CONTACT

54 92215081467; lopezsan@live.com.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 10, 2025
• Study Start: March 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: year 2026 no end date
• Access Criteria: free access. You are reporting that the URL does not appear to link to a functioning web page. But the URL is wotking

Locations

AR (1)