Omron Healthcare has announced the launch of a randomised controlled trial in collaboration with the University of California San Francisco (UCSF; San Francisco, USA) to evaluate a new model for the early detection of atrial fibrillation (AF) in hypertension patients using at-home blood pressure monitoring.
The fully remote clinical study—the OMRON-AF trial—will enrol approximately 1,900 hypertension patients aged 60 years and older who have risk factors for AF from users of the Omron Connect mobile app. Participants will be randomised into two groups: one using a home blood pressure monitor equipped with Omron’s Intellisense AF algorithm and the other using a standard monitor without AF detection functionality.
In cases where potential signs of AF are detected during routine home blood pressure monitoring, participants will receive a wearable patch electrocardiogram (ECG) device for confirmatory diagnosis. By integrating AF 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.
As detailed in an Omron press release, participants diagnosed with AF will also be assessed for heart failure risk via NT-proBNP biomarker testing, while AF burden—percentage of time spent in AF during a given monitoring period—as measured via patch ECG will be analysed against episode frequency recorded during home blood pressure monitoring in order to explore how at-home monitoring can support ongoing AF management after diagnosis.
“This collaboration with UCSF represents an important step toward integrating AF screening into routine hypertension management,” said Ayumu Okada, president and chief executive officer (CEO) of Omron Healthcare. “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’.”
“Unlike many other studies of various devices to screen for AF, we will be employing a randomised controlled trial, enabling a rigorous assessment that will test whether home blood pressure monitoring might be an effective tool to identify occult AF,” added Gregory Marcus (UCSF, San Francisco, USA). “This approach leverages common home-based evaluations that are already widely used in hypertension care. The study will also utilise remote recruitment and engagement, representing a particularly efficient approach that harnesses mobile app and smartphone-based technologies. We hope this research will help establish a new model for more appropriately identifying AF in high-risk patients with hypertension, and linking them to diagnosis and treatment, while also generating evidence that can be implemented in real-world clinical practice.”
