OMRON Healthcare Co., Ltd. has launched a randomized controlled trial in collaboration with the University of California, San Francisco to evaluate a new model for early detection of atrial fibrillation in hypertension patients using home blood pressure monitoring. Atrial fibrillation is a common cardiac arrhythmia closely linked to aging and high blood pressure and is associated with significantly elevated risk of stroke, heart failure, and cardiovascular mortality. Up to 40% of individuals with AFib may experience no noticeable symptoms, allowing the condition to remain undiagnosed until serious complications occur.
The fully remote clinical study, entitled Out-of-office Monitoring for Rhythms Of Normal versus Atrial Fibrillation: A Randomized Controlled Trial, will enroll approximately 1,900 hypertension patients aged 60 and older who have risk factors for atrial fibrillation from users of the OMRON Connect mobile app. Participants will be randomized into two groups: one using a home blood pressure monitor equipped with OMRON's Intellisense AFib algorithm and the other using a standard monitor without AFib detection functionality.
In cases where potential signs of AFib are detected during routine home blood pressure monitoring, participants will receive a wearable patch electrocardiogram device for confirmatory diagnosis. By integrating AFib screening into existing hypertension care pathways, the study aims to determine whether daily home blood pressure monitoring can improve early detection without increasing the burden on patients or healthcare systems. Participants diagnosed with AFib will also be assessed for heart failure risk via NT-proBNP biomarker testing, while AF burden as measured via patch ECG will be analyzed against episode frequency recorded during home blood pressure monitoring to explore how home monitoring can support ongoing AFib management after diagnosis.
"This collaboration with UCSF represents an important step toward integrating atrial fibrillation screening into routine hypertension management," said Ayumu Okada, President and CEO of OMRON Healthcare Co., Ltd. "By leveraging everyday home blood pressure monitoring habits, we aim to help reduce stroke and heart failure risk and advance our vision of 'Going for ZERO.'"
Professor Gregory Marcus of UCSF noted that unlike many other studies of various devices to screen for atrial fibrillation, this research employs a randomized controlled trial, enabling a rigorous assessment that will test whether home blood pressure monitoring might be an effective tool to identify occult atrial fibrillation. This approach leverages common home-based evaluations that are already widely used in hypertension care. The study will also utilize remote recruitment and engagement, representing a particularly efficient approach that harnesses mobile app and smartphone-based technologies.
For business and technology leaders, this trial represents a significant development in digital health integration and preventive care models. The study's remote design and use of existing consumer health technology platforms demonstrate how digital ecosystems can be leveraged for clinical research and population health management. If successful, this approach could establish a new standard for integrating cardiac screening into routine chronic disease management, potentially reducing healthcare costs associated with stroke and heart failure complications while improving patient outcomes through earlier intervention.
The research aims to generate evidence that can be implemented in real-world clinical practice, potentially transforming how high-risk patients are monitored and managed. For more information on this study, please visit https://healthcare.omron.com/health-resources/over-60-with-high-blood-pressure-why-checking-for-afib-matters.
