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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07582523
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood Pressure Monitor Without AFib Detection — DEVICE
    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.
  • Blood Pressure Monitor With AFib Detection — DEVICE
    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.

Study Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
1,910 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Standard Blood Pressure Monitoring (No AFib Detection)
    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.
  • Experimental: Intervention Blood Pressure Monitoring (AFib Detection)
    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.

Primary Outcome Measure

Time to first AFib diagnosis within 6 months after randomization [ Time Frame: Throughout and up to 6-months post randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at ParnassusSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
UCSF Medical Center at Parnassus· San Francisco, CA

Related Studies