Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
NCT Number: NCT06508619
Acronym: BPTreat
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Blood Pressure
Interventions: DEVICE: Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring
Sponsor: Corsano Health B.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-02
Completion Date: 2024-12-01
Locations: Reinier de Graaf Gasthuis, Delft, Zuid-Holland, 2625 AD, Netherlands

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.

Primary Outcome Measures: Baseline average BP for both CardioWatch 287-2 and reference, Baseline average blood pressure per patient and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately., Measured in each patient on 1st study day|Post-treatment average BP for both CardioWatch 287-2 and reference, Post-treatment average blood pressure and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately., Measured in each patient on 28th/last study day|Average BP change comparing CardioWatch 287-2 and reference, Absolute systolic and diastolic BP decrease and its standard deviation after change of treatment measured by the Corsano CardioWatch 287-2 after 28 days of monitoring, compared to automatic blood pressure cuff measurements., Measured in each patient on 28th/last study day
Secondary Outcome Measures: Bland-Altman for CardioWatch 287-2 vs. reference BP, Mean bias and limits of agreement between blood pressure measurements measured by the Corsano CardioWatch 287-2 and blood pressure measured by an automatic blood pressure cuff using a Bland Altman analysis., Measured in each patient on 28th/last study day|Pearson correlation coefficient between CardioWatch 287-2 vs. reference BP, Pearson correlation coefficient between blood pressure decrease measured by the Corsano CardioWatch 287-2 and blood pressure decrease measured by an automatic blood pressure cuff., Measured in each patient on 28th/last study day