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.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absolute decrease and standard deviation of SBP and DBP after change of
treatment measured by the Corsano Cardiowatch 287-2 after 28 days, compared to
blood pressure measured by an automatic blood pressure cuff.
Secondary outcome
(1) Mean bias and limits of agreement between blood pressure measured by the
Corsano CardioWatch 287-2 and blood pressure measured by an automatic blood
pressure cuff.
(2) Pearson correlation coefficient between blood pressure decrease measured by
the Corsano CardioWatch 287-2 and blood pressure decrease measured by an
automatic blood pressure cuff.
Background summary
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.
Study 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 design
Observational study in which 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 an automatic blood pressure cuff.
Study burden and risks
The study involves wearing of the Corsano CardioWatch 287-2 for 28 days and
blood pressure measurements at the beginning and ending of this period, which
does not impose a significant risk to the patient but does call on the
patient's time for a longer period of time. The study is necessary for the
evaluation of the Corsano CardioWatch 287-2 in its intended remote care
setting. The device has the potential to improve the monitoring of blood
pressure during antihypertensive drug treatment initiation, uptitration or
change in antihypertensive drugs, which can provide doctors with more insight
into a patient's hemodynamics. This potential can only be realized by
conducting the study and having patients wear the wristband at home for an
extended period of time during a change in antihypertensive treatment.
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85769.058.23 |