Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06508619

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

Led by Corsano Health B.V. · Updated on 2025-04-20

80

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 80 years old
  • Able to provide consent
  • Untreated or treated for hypertension with uncontrolled blood pressure
  • Medical indication for starting, increasing, or changing antihypertensive drug treatment prescribed by a doctor
Not Eligible

You will not qualify if you...

  • Unable to wear the Corsano CardioWatch 287-2 due to allergies, wounds, amputations, or similar reasons
  • Unable to receive blood pressure measurements with a cuff due to lymphedema, amputation, dialysis shunt, wounds, or similar conditions
  • Pregnant women
  • Breastfeeding women
  • Upper arm circumference outside the cuff range of 22-42 cm
  • Unable or unwilling to sign informed consent
  • Significant mental or cognitive impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands, 2625 AD

Actively Recruiting

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Research Team

M

Marjolein Muller, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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