Atrial Fibrillation (AF), High Blood Pressure, Hypertension (HTN)
Conditions
Keywords
Atrial Fibrillation, Hypertension, High Blood Pressure
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
Detailed description
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.
Interventions
DEVICEBlood 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.
DEVICEBlood 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
University of California, San Francisco
Omron Healthcare Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first AFib diagnosis within 6 months after randomization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of a Continuous ECG Monitor | 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. |
| Diagnostic Yield of High NT-proBNP Cases in Blood Tests | 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. |
| Time to First Occurrence of a 6-component Composite Event | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory M Marcus, MD, MAS
University of California, San Francisco
Outcome results
None listed