Blood Pressure Monitoring for Atrial Fibrillation
(OMRON-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is:
\-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection?
Participants will participate in two phases of the study: (1) clinical trial and (2) the registry.
During the 6-month clinical trial period, participants will be asked to:
* Take blood pressure measurements twice daily
* Answer short weekly mobile app-based surveys
* If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
* Take blood pressure measurements twice daily
* Answer monthly mobile app-based surveys
Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events.
Participants will participate in two phases of the study: (1) trial and (2) the registry.
During the 6-month trial period, participants will be asked to:
* Take daily blood pressure measurements
* Answer short weekly mobile app-based surveys
* If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
* Take daily blood pressure measurements
* Answer monthly mobile app-based surveys
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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.