Home Blood Pressure Monitoring Methods for High Blood Pressure

(CHANGE-BP Trial)

Overseen By Josep Sola, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aktiia SA

Disqualifiers: Diabetes, Hyperthyroidism, Pregnancy, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for monitoring high blood pressure at home. One group will use a new wristband device for Continual Blood Pressure Monitoring (CBPM), which sends data to a smartphone app and connects with healthcare providers. The other group will use a standard blood pressure cuff for Home Blood Pressure Monitoring (HBPM) with care from their regular doctor. This trial suits individuals with high blood pressure readings above 140/90 in the past 18 months, who own a smartphone, and are willing to participate in regular check-ins. As an unphased trial, it offers a unique opportunity to contribute to innovative research in blood pressure management.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these blood pressure monitoring methods are safe?

Previous studies have shown that devices like the Aktiia bracelet, which continuously monitor blood pressure, hold promise for tracking blood pressure throughout the day and night. Designed for comfort, these devices provide ongoing data without the need for a traditional cuff and are generally considered safe as they do not invade the body.

Research indicates that home blood pressure monitoring, which uses a standard cuff, is well-tolerated by users. This method has been used for a long time and often aids in managing high blood pressure. Users typically do not report significant side effects, as it offers a simple and safe way to track blood pressure.

Both continuous and home blood pressure monitoring are generally safe and well-tolerated, providing valuable information to help manage high blood pressure without causing notable harm to users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage high blood pressure at home. Unlike traditional methods, which usually rely on periodic checks with an upper arm cuff, the trial investigates the potential of continuous blood pressure monitoring (CBPM) using the Aktiia Bracelet. This device offers real-time tracking, potentially providing a more comprehensive picture of a person's blood pressure throughout the day. By comparing CBPM with home blood pressure monitoring (HBPM), which involves standard care with an upper arm cuff, researchers aim to find out if continuous monitoring can lead to better blood pressure management and more personalized treatment plans.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

In this trial, participants will be assigned to one of two methods for managing high blood pressure. Research has shown that the Aktiia cuffless blood pressure monitor, used for Continual Blood Pressure Monitoring (CBPM), provides readings similar to traditional 24-hour monitors. Studies have found it can accurately measure blood pressure in various body positions, suggesting it could effectively help manage high blood pressure. Participants in the Home Blood Pressure Monitoring (HBPM) arm will use an upper arm cuff and receive standard hypertension care from their primary care physician. HBPM has been proven to lower blood pressure when combined with additional medical support. Evidence from different trials indicates that HBPM can lead to better long-term blood pressure control. Both methods show promise in managing high blood pressure, each with its own advantages. ^{6 7 8 9 10}

Who Is on the Research Team?

Aaron Shoenkerman, MD

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with high blood pressure, who are patients of Providence Health, own a smartphone with data plan, and can attend two in-person visits. They must not have severe kidney disease, certain heart conditions or be on specific treatments that affect blood pressure.

Inclusion Criteria

Owns a smartphone that is an Android or iOS with a data plan

I am between 21 and 80 years old.

I am fluent in both written and spoken English.

Exclusion Criteria

I am currently receiving or will receive chemotherapy through IV.

Your heart beats very fast even when you are not active.

My heart's pumping ability is significantly reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants attend a baseline visit for surveys and measurements before randomization

1 day

1 visit (in-person)

Treatment

Participants are randomized to either CBPM or HBPM groups for blood pressure monitoring and management

6 months

Ongoing monitoring with potential medication titration

End of Study

Participants return for an end of study visit for surveys and measurements

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any long-term effects or outcomes post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continual Blood Pressure Monitoring (CBPM)
• Home Blood Pressure Monitoring (HBPM)
• Upper arm cuff

Trial Overview The CHANGE-BP study compares continual monitoring using the Aktiia cuffless BP system and app against routine home monitoring with a standard arm cuff. The goal is to see which method better manages high blood pressure over six months.

How Is the Trial Designed?

Group I: Continuous Blood Pressure Monitoring (CBPM) Experimental Treatment 1 Intervention

Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.

Group II: Home Blood Pressure Monitoring (HBPM) Active Control 1 Intervention

Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.

Who Is Running the Clinical Trial?

Aktiia SA

Lead Sponsor

Trials

12

Recruited

23,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05746117

Study Details | NCT05746117 | Continual vs. Routine ... The Aktiia Bracelet is a non-invasive blood pressure monitor intended to track systolic and diastolic blood pressure and heart rate. Participants will attend a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997243/

Continual Versus Occasional Blood Pressure (COOL-BP) in ... Secondary endpoints included concordance between HBPM and cuffless pressures following a medication titration, and patient satisfaction with the cuffless device ...

3. journals.lww.com journals.lww.com/jhypertension/fulltext/2025/04000/evaluation_of_aktiia_cuffless_blood_pressure.16.aspx

Evaluation of Aktiia cuffless blood pressure monitor across ... This study evaluated BP readings from a cuffless, continual BP monitor (Aktiia monitor, Neuchâtel, Switzerland) and a standard 24-h ambulatory BP monitor (ABPM)

4. nature.com nature.com/articles/s41598-021-99294-w

Validation of the optical Aktiia bracelet in different body ... This study demonstrates that a wearable device can accurately estimate BP in the most common body positions compared to auscultation, although precision varies ...

5. healthcare.aktiia.com healthcare.aktiia.com/aktiia-cuffless-blood-pressure-monitor-yields-equivalent-daytime-blood-pressure-measurements-compared-to-a-24-h-ambulatory/

Aktiia cuffless blood pressure monitor yields equivalent ... Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842120/

The Promise and Illusion of Continuous, Cuffless Blood ... Cuffless, wearable BP devices offer the promise of beat-to-beat, continuous, noninvasive measurement of BP during both awake and sleep periods with minimal ...

7. academic.oup.com academic.oup.com/ajh/advance-article/doi/10.1093/ajh/hpaf097/8154826

Remote Blood Pressure Monitoring: A Comprehensive Review This technology at home allows for the detection of instantaneous fluctuations in BP that could be predictive of cardiovascular disease events.

8. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/16330-24-hour-ambulatory-blood-pressure-monitoring

24-Hour Ambulatory Blood Pressure Monitoring Ambulatory blood pressure monitoring is a method to measure your blood pressure on a continuous basis for 24 hours. It helps diagnose and treat high blood ...

9. nature.com nature.com/articles/s41371-023-00850-w

Blood pressure outcomes at 12 months in primary care ... Outcomes at 3, 6, 9 and 12 months were: controlling high BP (most recent BP < 140/90 mm Hg), antihypertensive medication intensification, and ...

10. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=294

Ambulatory Blood Pressure Monitoring (ABPM) In 6 studies, each 10–mm Hg increment in 24-hour systolic ABPM, adjusted for OBPM, was associated with an increased risk for fatal and nonfatal cardiovascular ...