Status:
RECRUITING
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Lead Sponsor:
Corsano Health B.V.
Conditions:
High Blood Pressure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure. The device has been validated us...
Detailed Description
Background and Introduction: Blood pressure (BP) is a cardiovascular risk factor that affects millions of people worldwide. BP is a major determinant of stroke, heart failure, coronary artery disease...
Eligibility Criteria
Inclusion
- aged between 18 and 80 years old;
- able to provide consent;
- untreated or treated for hypertension, with uncontrolled BP and medical indication for antihypertensive drug initiation or uptitration or change in antihypertensive drug per doctor prescription.
Exclusion
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- Pregnant women;
- Breastfeeding women;
- Upper arm circumference not within the cuff range (22-42 cm)
- Unable or not willing to sign for informed consent;
- Significant mental or cognitive impairment.
Key Trial Info
Start Date :
July 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06508619
Start Date
July 2 2024
End Date
August 1 2025
Last Update
April 20 2025
Active Locations (1)
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1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625 AD