Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation

Summary

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

Conditions

• Atrial Fibrillation (AF)
• Hypertension (HTN)
• High Blood Pressure

Interventions

DEVICE

Blood Pressure Monitor Without AFib Detection

Participants with this intervention 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 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements.

DEVICE

Blood Pressure Monitor With AFib Detection

Participants with this intervention 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.

Sponsors & Collaborators

• Omron Healthcare Co., Ltd.

  collaborator INDUSTRY

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Gregory M Marcus, MD, MAS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2029-04-30

Completion

2029-04-30

FDA Device

Yes

Countries

• United States

Study Locations