Home monitoring for hidden atrial fibrillation in people with hypertension
Official title: Home Monitoring for the Detection of Subclinical Atrial Fibrillation in Hypertensive Patients at Moderate to High Risk of Developing Arrhythmia. BP/AF MODE Study.
Run by Cardiovascular Research Center Rosario British Sanatorium · NCT07058831 · Data updated 2026-11-12
This project will test whether using a home blood-pressure device that also records short ECGs can find hidden atrial fibrillation in older people with high blood pressure and other risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 499 (estimated) |
| Sponsor | Cardiovascular Research Center Rosario British Sanatorium Academic / other |
| Locations | 1 site (Rosario, Santa Fe Province) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07058831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Hypertensive adults aged over 75, or aged 65–75 with one or more specified risk factors (for example obesity, diabetes, sleep apnea, left ventricular hypertrophy, left atrial dilation, coronary disease, chronic kidney disease, HFpEF, alcohol use, or frequent supraventricular ectopy), who have no prior AF and are not on rhythm-altering medications.
✕Probably not a fit
People with a history of any atrial fibrillation, those taking drugs that affect heart rhythm, with prior malignant ventricular arrhythmias, uncontrolled thyroid disease, or significant COPD are excluded and are unlikely to benefit from this monitoring protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational cohort across six Latin American countries that gives hypertensive patients an Omron Complete Hem-7530T device to record blood pressure and 30-second single-lead ECGs at home. Participants are older adults (>75 years, or 65–75 with specified risk factors) without prior atrial fibrillation and will perform at least twenty 30-second recordings over seven days. Data are entered into a secure web platform, and novel artificial-intelligence tools are used alongside ECG review to identify subclinical atrial fibrillation. The goal is to determine how useful routine home BP/ECG monitoring is for detecting asymptomatic AF in this higher-risk population.
Why it matters
Potential benefit: If successful, the approach could enable earlier detection of silent AF so patients can receive preventive care to reduce stroke risk.
How similar studies have gone: Prior work using single-lead ECGs, wearables, and AI algorithms has shown these tools can detect subclinical AF, so this study builds on accumulating supportive evidence rather than testing an entirely unproven concept.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. Obesity 2. Type 2 diabetes 3. Obstructive sleep apnea syndrome 4. Electrocardiogram showing left ventricular hypertrophy. 5. Left ventricular hypertrophy on echocardiogram. 6. Left atrial dilation. 7. Coronary artery disease 8. Chronic kidney disease 9. Heart failure with ejection fraction \> 50% 10. Alcohol intake 11. Frequent supraventricular ectopic beats Exclusion Criteria: * 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.
Where it's running
-
British Sanatorium Cardiovascular Research Center
Rosario, Santa Fe Province, Argentina Recruiting
Study contacts
- Study coordinator: Daniel L Piskorz, MD
- Email: daniel.l.piskorz@gmail.com
- Phone: 5493415416828
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.