Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Corsano Health B.V.
80 participants
Jul 2, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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.
Interventions
Patients receive Corsano CardioWatch 287-2 for continous NIBP monitoring and perform several spot-checks using an automated BP cuff as a reference during the start or uptitration of BP lowering medication
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06508619