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

Trial Summary

What is the purpose of this trial?

The purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an accompanying Aktiia Patient Interface smartphone application, and care delivered through a centralized Aktiia Provider Interface that displays device data and is accessible by a health care professional or 2) Home Blood Pressure Monitoring (HBPM), which includes a standard oscillometric blood pressure cuff and the standard blood pressure management care from a participant's primary care physician.

Research Team

Aaron Shoenkerman, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+