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

NCT07582523 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-45123
• Study Type: interventional
• Target: 1,910
• Locations: 1 country
• Sites: 1

Brief 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); High Blood Pressure; Hypertension (HTN)

Keywords

Atrial Fibrillation; Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Time to first AFib diagnosis within 6 months after randomization

  The primary outcome will be time to AFib diagnosis, defined as the earliest AFib confirmed on a study continuously-recording ECG patch, or AFib clinically diagnosed during usual care (recorded by a treating clinician in the medical record, independent of study ECG patch confirmation).

  Throughout and up to 6-months post randomization

Secondary Outcomes (3)

• Diagnostic Yield of a Continuous ECG Monitor

  Throughout and up to 6-months post randomization

• Diagnostic Yield of High NT-proBNP Cases in Blood Tests

  Throughout and up to 6-months post randomization

• Time to First Occurrence of a 6-component Composite Event

  Throughout 18-month study enrollment

Study Arms (2)

Standard Blood Pressure Monitoring (No AFib Detection)

EXPERIMENTAL

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.

Device: Blood Pressure Monitor Without AFib Detection

Intervention Blood Pressure Monitoring (AFib Detection)

EXPERIMENTAL

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.

Device: Blood Pressure Monitor With AFib Detection

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.

Also known as: BP5255, OMRON Silver Upper Arm Blood Pressure Monitor

Standard Blood Pressure Monitoring (No AFib Detection)

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.

Also known as: BP7360, OMRON 7 Series Upper Arm Blood Pressure Monitor

Intervention Blood Pressure Monitoring (AFib Detection)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Omron Healthcare Co., Ltd.: collaborator

Study Sites (1)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

Location

Related Publications (15)

• UK National Screening Committee. https://view-health-screening-recommendations.service.gov.uk/atrial-fibrillation/. (2019).

  BACKGROUND

• Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. doi: 10.1093/eurheartj/ehae373.

  PMID: 38953776 BACKGROUND

• Daniel E. Singer et al., J Am Coll Cardiol EP., 2025, 11(1), 110-119

  BACKGROUND

• US Preventive Services Task Force, JAMA, 2022, 327(4), 360-367.

  BACKGROUND

• Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.

  PMID: 39217615 BACKGROUND

• Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.

  PMID: 34469766 BACKGROUND

• Lopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE. Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention. J Am Coll Cardiol. 2024 Nov 19;84(21):2073-2084. doi: 10.1016/j.jacc.2024.08.019. Epub 2024 Sep 1.

  PMID: 39230544 BACKGROUND

• Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.

  PMID: 29998336 BACKGROUND

• Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.

  PMID: 33625468 BACKGROUND

• Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.

  PMID: 28851729 BACKGROUND

• Lubitz SA, Faranesh AZ, Atlas SJ, McManus DD, Singer DE, Pagoto S, Pantelopoulos A, Foulkes AS. Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study. Am Heart J. 2021 Aug;238:16-26. doi: 10.1016/j.ahj.2021.04.003. Epub 2021 Apr 15.

  PMID: 33865810 BACKGROUND

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 BACKGROUND

• Karakasis P, Pamporis K, Siontis KC, Theofilis P, Samaras A, Patoulias D, Stachteas P, Karagiannidis E, Stavropoulos G, Tzikas A, Kassimis G, Giannakoulas G, Karamitsos T, Katritsis DG, Fragakis N. Major clinical outcomes in symptomatic vs. asymptomatic atrial fibrillation: a meta-analysis. Eur Heart J. 2025 Apr 1;46(13):1189-1202. doi: 10.1093/eurheartj/ehae694.

  PMID: 39428997 BACKGROUND

• Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.

  PMID: 38033089 BACKGROUND

• Noubiap JJ, Tang JJ, Teraoka JT, Dewland TA, Marcus GM. Minimum National Prevalence of Diagnosed Atrial Fibrillation Inferred From California Acute Care Facilities. J Am Coll Cardiol. 2024 Oct 15;84(16):1501-1508. doi: 10.1016/j.jacc.2024.07.014. Epub 2024 Sep 11.

  PMID: 39269390 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Gregory M Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)