Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Reinier de Graaf Gasthuis
RECRUITING
Delft
Contact Information
Primary
Marjolein Muller, MSc
marjolein@corsano.com
+31658950301
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 80
Treatments
Experimental: Patients receiving blood pressure lowering medication (uptitration) as standard of care
Patients receiving blood pressure lowering medication (uptitration) as standard of care
Related Therapeutic Areas
Sponsors
Leads: Corsano Health B.V.

This content was sourced from clinicaltrials.gov