By InvitationNot Applicable

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

United States1,910 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Hypertensive\* patients aged 60 years or older living in the United States who meet at least one of the following criteria: * ≥70 years old * BMI ≥30kg/m2 * CHA2DS2-VASc ≥3 (excluding Female sex) Exclusion Criteria: * Current or prior diagnosis of atrial fibrillation (AFib), atrial flutter, or atrial tachycardia * Receiving anticoagulation therapy * History of skin allergies to adhesive patches * Open wound or skin inflammation, such as eczema, in the chest region. * Inability to wear the patch ECG monitor or apply the monitor by herself/himself or with the help of a caregiver * Individuals who are currently using home medical devices or wearable devices capable of detecting atrial fibrillation and are unwilling to refrain from using such AF detection device features during the randomized controlled trial (RCT) phase of the study * People who have a mailing address in Alaska, Hawaii, or a U.S. territory

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to first AFib diagnosis within 6 months after randomization

Timeframe: Throughout and up to 6-months post randomization

Trial details

NCT IDNCT07582523

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials