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

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

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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