RecruitingNot ApplicableNCT06508619

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


Sponsor

Corsano Health B.V.

Enrollment

80 participants

Start Date

Jul 2, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a smartwatch-like wristband device (the Corsano CardioWatch 287-2) can accurately monitor blood pressure and guide treatment adjustments for people with uncontrolled high blood pressure, potentially making it easier to manage this condition from home. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with high blood pressure (hypertension) that is currently uncontrolled - Your doctor has recommended starting or changing your blood pressure medication - You are able to provide consent and wear the wristband device **You may NOT be eligible if...** - You cannot wear the wristband (e.g., due to skin allergies, wounds, or amputation) - You cannot have a standard blood pressure cuff on your arm (e.g., due to lymphedema or dialysis shunt) - You are pregnant or breastfeeding - Your upper arm size is outside the range that fits a standard cuff Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECorsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring

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)

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

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NCT06508619


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