Actively Recruiting
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Led by Corsano Health B.V. · Updated on 2025-04-20
80
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 using clinical trials in hospitals, but evaluation in the intended remote setting during treatment is lacking. Primary objective: To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs. Study population: A group, untreated or treated for hypertension, with uncontrolled BP and medical indication for antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs. Study design: Blood pressure will be measured by the investigative device and a reference device at pre-treatment and after 28 days. The investigative device is the Corsano CardioWatch 287-2, which measures blood pressure through optical photoplethysmography (PPG). The reference method involves automatic blood pressure cuff measurements. Main study parameters/endpoints: Absolute systolic and diastolic blood pressure decrease after change of treatment measured by the Corsano Cardiowatch 287-2 after 28 days, compared to automatic blood pressure cuff measurements.
CONDITIONS
Official Title
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years old
- Able to provide consent
- Untreated or treated for hypertension with uncontrolled blood pressure
- Medical indication for starting, increasing, or changing antihypertensive drug treatment prescribed by a doctor
You will not qualify if you...
- Unable to wear the Corsano CardioWatch 287-2 due to allergies, wounds, amputations, or similar reasons
- Unable to receive blood pressure measurements with a cuff due to lymphedema, amputation, dialysis shunt, wounds, or similar conditions
- Pregnant women
- Breastfeeding women
- Upper arm circumference outside the cuff range of 22-42 cm
- Unable or unwilling to sign informed consent
- Significant mental or cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625 AD
Actively Recruiting
Research Team
M
Marjolein Muller, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here