NCT07058831Recruiting
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.
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 499 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Cardiovascular Research Center Rosario British Sanatorium
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT07058831
What you commit to
- Study type: Observational
- Planned participants: 499
- From 1 Mar 2025 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| British Sanatorium Cardiovascular Research Center Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
Related publications
- Home monitoring for the detection of atrial fibrillation in hypertensive patients. BP/AF MODE study.Arch Cardiol Mex · 2026 · PMID 41525689
This page is information, not medical advice. Discuss any trial with your doctor.