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. The study represents a significant advancement in cardiovascular care by integrating AFib screening into existing hypertension management pathways that millions of patients already follow.
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. The condition presents a particular challenge because up to 40% of individuals with AFib may experience no noticeable symptoms, allowing it to remain undiagnosed until serious complications occur. This silent progression makes early detection crucial for preventing devastating health outcomes.
The fully remote clinical study, entitled Out-of-office Monitoring for Rhythms Of Normal versus Atrial Fibrillation: A Randomized Controlled Trial (OMRON-AF 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.
When potential signs of AFib are detected during routine home blood pressure monitoring, participants will receive a wearable patch electrocardiogram device for confirmatory diagnosis. This approach aims to determine whether daily home blood pressure monitoring can improve early detection without increasing the burden on patients or healthcare systems. The study will also assess heart failure risk via NT-proBNP biomarker testing for participants diagnosed with AFib and analyze AF burden against episode frequency recorded during home monitoring.
"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 emphasized the study's rigorous methodology, stating, "Unlike many other studies of various devices to screen for atrial fibrillation, we will be employing 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 utilizes remote recruitment and engagement through mobile app and smartphone-based technologies, representing an efficient approach that could establish a new model for identifying atrial fibrillation in high-risk patients with hypertension. 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.
