Blood Pressure Monitoring for Atrial Fibrillation
(OMRON-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special blood pressure monitor that detects atrial fibrillation (AFib) can diagnose AFib faster in individuals with high blood pressure. AFib, a common irregular heart rhythm, can lead to serious health issues. Participants will use either a regular blood pressure monitor or one that detects AFib, and researchers will compare the results over time. This trial suits individuals aged 60 or older in the U.S. with high blood pressure who meet specific health criteria, such as being overweight. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance AFib diagnosis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on blood pressure monitoring and AFib screening.
What prior data suggests that this blood pressure monitoring method is safe for atrial fibrillation screening?
Research has shown that blood pressure monitors with AFib (atrial fibrillation) detection are generally safe to use. OMRON blood pressure monitors with this feature have been well-studied and are known for their high accuracy. Specifically, one study found that these monitors correctly identified AFib 99% of the time and rarely gave false alarms, with a 93% accuracy rate.
This technology has undergone testing in clinical settings and received FDA approval for its accuracy and effectiveness in detecting AFib during regular blood pressure checks. No major reports of problems have emerged from using these devices for screening, indicating they are well-tolerated by users. Therefore, for those considering joining a trial that uses this technology, current evidence supports its safety for everyday use.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative methods for monitoring atrial fibrillation (AFib). Unlike standard blood pressure monitors, the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) features built-in AFib detection. This could offer a more comprehensive approach to managing patients' heart health by catching AFib episodes early. The trial aims to determine if integrating AFib detection into routine blood pressure monitoring can improve patient outcomes and provide new insights into managing cardiovascular health.
What evidence suggests that using a blood pressure monitor with AFib detection is effective for diagnosing atrial fibrillation?
Research has shown that blood pressure monitors with features to detect AFib, a type of irregular heartbeat, are highly effective. One study found these monitors to be about 99% accurate, with a 100% true positive rate and a 98.6% true negative rate. Another study confirmed that these monitors reliably spot AFib during regular checks. In this trial, participants in the intervention arm will use blood pressure monitors with AFib detection features, which experts have clinically validated. These devices can help detect AFib earlier than traditional methods, potentially speeding up diagnosis in people with high blood pressure.23467
Who Is on the Research Team?
Gregory M Marcus, MD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people aged 70 or older who have high blood pressure, a BMI of at least 30, and a moderate-to-high risk of stroke (CHA2DS2-VASc score of 3 or more).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Clinical Trial
Participants take daily blood pressure measurements and answer weekly surveys. If assigned, they complete continuous heart monitoring for 2 weeks and a blood test.
Registry
Participants continue daily blood pressure measurements and answer monthly surveys to assess cardiovascular events and AFib occurrence.
Follow-up
Participants are monitored for safety and effectiveness after the registry phase.
What Are the Treatments Tested in This Trial?
Interventions
- Blood Pressure Monitor With AFib Detection
- Blood Pressure Monitor Without AFib Detection
Trial Overview
The study compares two types of home blood pressure monitors: one with atrial fibrillation (AFib) detection technology and one without. It aims to see if AFib screening helps diagnose irregular heart rhythms faster in older adults with high blood pressure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements.
Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Omron Healthcare Co., Ltd.
Industry Sponsor
Citations
Atrial Fibrillation Screening During Routine Automated ...
There is considerable and consistent evidence suggesting high diagnostic accuracy of AF detection algorithms implemented in automated BP monitors during ...
AFib Detection Technology
OMRON blood pressure monitors with AFib Screening Technology are clinically validated to detect the possibility of AFib while taking your routine blood pressure ...
FEATURE (BP7460 (HEM-7371T1-AZ)) - accessdata.fda.gov
The feature analyzes pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of atrial fibrillation (AFib) and ...
Diagnostic Performance of Automated Blood Pressure Monitor ...
The accuracy index of the Rossmax X5 ABPM for AF detection was about 99%. The sensitivity and specificity were 100% and 98.6%, respectively (Table 2). Out of ...
Evaluation of the performance of a machine learning based ...
These results reflect the high accuracy and robustness of this AFib algorithm using a single BP measurement and supports its use for widespread AFib screening.
Detection of Atrial Fibrillation Using a Home Blood Pressure ...
This study investigated the diagnostic accuracy of an automated device for home blood pressure (BP) monitoring, which implements an algorithm for AF detection.
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prnewswire.com
prnewswire.com/news-releases/omron-healthcare-evolves-the-blood-pressuring-experience-with-ai-powered-afib-detection-302462542.htmlOMRON Healthcare Evolves the Blood Pressuring ...
A published clinical study found that OMRON blood pressure monitors with Intellisense AFib can detect disturbances specific to AFib with ...
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