Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Recruiting
- Conditions
- high blood pressurehypertension10057166
- Registration Number
- NL-OMON56722
- Lead Sponsor
- Corsano Health B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
* aged between 18 and 80 years old;
* able to provide consent;
* has uncontrolled blood pressure and medical indication for antihypertensive
drug treatment initiation, uptitration or change in antihypertensive drugs.
Exclusion Criteria
* 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, dyalisis shunt, wounds, etc.;
* pregnant women;
* breastfeeding women;
* upper arm circumference not within the cuff range (22-42 cm)
* unable or not willing to sign informed consent;
* significant mental or cognitive impairment
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Absolute decrease and standard deviation of SBP and DBP after change of<br /><br>treatment measured by the Corsano Cardiowatch 287-2 after 28 days, compared to<br /><br>blood pressure measured by an automatic blood pressure cuff.</p><br>
- Secondary Outcome Measures
Name Time Method <p>(1) Mean bias and limits of agreement between blood pressure measured by the<br /><br>Corsano CardioWatch 287-2 and blood pressure measured by an automatic blood<br /><br>pressure cuff.<br /><br>(2) Pearson correlation coefficient between blood pressure decrease measured by<br /><br>the Corsano CardioWatch 287-2 and blood pressure decrease measured by an<br /><br>automatic blood pressure cuff.</p><br>