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, 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 research matters because it addresses a critical gap in cardiovascular care where many individuals with atrial fibrillation remain undiagnosed until they experience serious complications like stroke. The study's approach leverages existing home monitoring practices that hypertension patients already perform regularly, potentially creating a seamless screening method that doesn't require additional healthcare visits or specialized equipment. For more information on this study, please visit the OMRON Healthcare resource page.
"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 added 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.
The study's implications extend beyond individual patient care to potential healthcare system benefits. If successful, this approach could establish a new model for identifying atrial fibrillation in high-risk patients with hypertension and linking them to diagnosis and treatment while generating evidence that can be implemented in real-world clinical practice. The remote recruitment and engagement methods represent a particularly efficient approach that harnesses mobile app and smartphone-based technologies, potentially making screening more accessible to diverse populations. This research could ultimately lead to earlier interventions for atrial fibrillation, potentially preventing strokes and heart failure events that result in significant healthcare costs and reduced quality of life.
