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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
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 moreAwards & 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
11 Previous Clinical Trials
23,519 Total Patients Enrolled
Aaron Shoenkerman, MDPrincipal InvestigatorProvidence Health & Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have an abnormal connection between an artery and a vein.I am between 21 and 80 years old.I have a skin condition that causes peeling or scaling.I have a narrowed subclavian artery.I am fluent in both written and spoken English.I experience trembling and shivering.I am willing to go to 2 in-person study visits.I have had an arm amputated.You had a bone mineral density test in the last 12 months, or are willing to get one if the clinical pharmacist thinks it's necessary.I have ongoing or long-term atrial fibrillation.I have been diagnosed with pheochromocytoma.Your upper arm is too small or too big for this study.My doctor expects I have less than 2 years to live due to my condition.My kidney function is severely reduced.You have an allergy to silicone.I have myxedema coma.I have Raynaud's disease.I am currently being treated for an overactive thyroid.I have swelling in my arms or legs due to lymph fluid buildup.Your wrist size is smaller than 14 cm or larger than 21 cm.I need someone legally authorized to make medical decisions for me.You have been diagnosed with white coat hypertension.You are currently on hospice care or will be going on hospice care within the next 6 months.I have diabetes.Your blood pressure has been consistently high, or it was high during your last doctor's visit.I am willing to be assigned to any treatment group by chance.Is a patient receiving care from Providence Health.Your blood pressure at the start of the study is either too low or too high.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Blood Pressure Monitoring (CBPM)
- Group 2: Home Blood Pressure Monitoring (HBPM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT05746117 — N/A