Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation (OMRON-AF)
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
Přehled studie
Postavení
Detailní popis
This prospective, randomized controlled trial and registry aims to compare the diagnosis rate of Atrial Fibrillation (AFib) in participants with high blood pressure (BP) using either (1) a BP monitor with AFib detection technology or (2) a conventional BP monitor without AFib detection technology. Eligible participants are those who are English speaking individuals with a mailing address in the contiguous U.S., over the age of 60 with high blood pressure and meet one or more of the following:
- 70 years old or older
- BMI of 30 kg/m2 or greater -- CHA2DS2-VASc greater than or equal to 3 (excluding Female sex)
For the first 6 months, participants will be randomly assigned to use one of two blood pressure monitors, one with AFib detection (intervention group) or one without (control group). Those randomly assigned to the AFib detection BP monitor will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, if an intervention group participant is notified by their device that potential AFib has been detected, they will be asked to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. Those randomly assigned to the BP monitor without AFib detection will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, control group participants in this group may be randomly assigned to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. An equal number from both groups will be selected.
Following the first 6 months, participants will enter a 12-month 'Registry' phase. Participants in the control arm will receive a BP cuff with AFib detection technology. All participants will be asked to take daily measurements (4 daily, 2 in the morning and 2 at night) using the BP monitor with AFib detection and answer monthly mobile-app surveys. These surveys will be used to assess cardiovascular related events and any AFib occurrence. Some participants may be contacted for additional information. About 1,910 participants will be enrolled in this study.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
San Francisco, California, Spojené státy, 94143
- UCSF Medical Center at Parnassus
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
Ostatní jména:
|
|
Experimentální: 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.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to first AFib diagnosis within 6 months after randomization
Časové okno: Throughout and up to 6-months post 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Diagnostic Yield of a Continuous ECG Monitor
Časové okno: Throughout and up to 6-months post randomization
|
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
|
Throughout and up to 6-months post randomization
|
|
Diagnostic Yield of High NT-proBNP Cases in Blood Tests
Časové okno: Throughout and up to 6-months post randomization
|
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
|
Throughout and up to 6-months post randomization
|
|
Time to First Occurrence of a 6-component Composite Event
Časové okno: Throughout 18-month study enrollment
|
Throughout the course of the 18-months of participation, participants will answer mobile-app based surveys regarding occurrence of cardiovascular health events including (1) ischemic stroke/TIA, (2) myocardial infarction [MI], (3) noncentral nervous system [CNS] embolism or thrombosis, (4) hospitalization or emergency department visit for HF, (5) cardiovascular hospitalization or (6) all-cause mortality.
A secondary outcome will be a comparison of the time to the first occurrence of these cardiovascular health-related events between individuals who detected AFib by a continuous ECG monitor or by Pressure Pulse Wave (PPW) blood pressure monitor (with AFib detection) and those who did not.
|
Throughout 18-month study enrollment
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gregory M Marcus, MD, MAS, University of California, San Francisco
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- UK National Screening Committee. https://view-health-screening-recommendations.service.gov.uk/atrial-fibrillation/. (2019).
- Daniel E. Singer et al., J Am Coll Cardiol EP., 2025, 11(1), 110-119
- US Preventive Services Task Force, JAMA, 2022, 327(4), 360-367.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Další relevantní podmínky MeSH
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