Status:
COMPLETED
COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
Lead Sponsor:
Aktiia SA
Conditions:
Hypertension
Eligibility:
All Genders
26-80 years
Phase:
NA
Brief Summary
The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote ...
Detailed Description
This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to tra...
Eligibility Criteria
Inclusion
- Fluent in written and spoken English
- Already enrolled in the Remote Hypertension Program
- Average of last 3 office blood pressures \>140/90 mm Hg in last 18 months OR Last office blood pressure \>140/90 mm Hg in last 6 months OR Referred by MD and last 1 blood pressure \>130/80 mm Hg
- Own an iPhone
Exclusion
- Tachycardia (heart rate at rest \> 120bpm)
- Atrial fibrillation, persistent
- Severe heart failure (LVEF\<35%)
- Pheochromocytoma
- Raynaud's disease
- Trembling and shivering
- Known pregnancy
- Breastfeeding
- Arteriovenous fistula
- Arm amputation
- Exfoliative skin disease
- Lymphoedema
- Known allergy to silicone
- Not Massachusetts resident
- Last MGB office visit \>3 years
- No-MGB provider
- Terminal medical condition
- CKD 4-5 (eGFR ≤ 30 mL/mn)
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05211648
Start Date
February 10 2022
End Date
May 23 2023
Last Update
May 24 2023
Active Locations (1)
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1
Harvard Medical School
Boston, Massachusetts, United States, 02115