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Home Blood Pressure Monitoring Methods for High Blood Pressure (CHANGE-BP Trial)

N/A
Waitlist Available
Led By Aaron Shoenkerman, MD
Research Sponsored by Aktiia SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-80 years old
Fluent in written and spoken English as the technology is currently only available in English
Must not have
Pheochromocytoma
Currently undergoing or will undergo active IV infusions for chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
No Placebo-Only Group

Summary

This trial compares 2 methods of BP monitoring over 6 months to see which is more effective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from wearing the devices or skin irritation due to materials like silicone in the Aktiia bracelet. However, these devices are generally considered safe and non-invasive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.
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I am fluent in both written and spoken English.
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I am willing to go to 2 in-person study visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with pheochromocytoma.
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I am currently receiving or will receive chemotherapy through IV.
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My heart's pumping ability is significantly reduced.
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I have had an arm amputated.
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I have a skin condition that causes peeling or scaling.
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I have a narrowed subclavian artery.
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I have ongoing or long-term atrial fibrillation.
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My doctor expects I have less than 2 years to live due to my condition.
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My kidney function is severely reduced.
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I have myxedema coma.
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I have Raynaud's disease.
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I am currently being treated for an overactive thyroid.
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I have swelling in my arms or legs due to lymph fluid buildup.
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I need someone legally authorized to make medical decisions for me.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in blood pressure
Secondary study objectives
Participant compliance
Participant engagement
Participant perception
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Blood Pressure Monitoring (CBPM)Experimental Treatment1 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 Control1 Intervention
Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.

Find a Location

Who is running the clinical trial?

Aktiia SALead Sponsor
10 Previous Clinical Trials
23,254 Total Patients Enrolled
Aaron Shoenkerman, MDPrincipal InvestigatorProvidence Health & Services

Media Library

Continual Blood Pressure Monitoring (CBPM) Clinical Trial Eligibility Overview. Trial Name: NCT05746117 — N/A
High Blood Pressure Research Study Groups: Continuous Blood Pressure Monitoring (CBPM), Home Blood Pressure Monitoring (HBPM)
High Blood Pressure Clinical Trial 2023: Continual Blood Pressure Monitoring (CBPM) Highlights & Side Effects. Trial Name: NCT05746117 — N/A
Continual Blood Pressure Monitoring (CBPM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746117 — N/A
High Blood Pressure Patient Testimony for trial: Trial Name: NCT05746117 — N/A
~333 spots leftby May 2026
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