Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,910
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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