Monitoring blood pressure with the Corsano CardioWatch 287-2 device
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
This study is testing a new wearable device that continuously monitors blood pressure to see if it works well for people with high blood pressure who are not well controlled on their current treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Corsano Health B.V. Industry-sponsored |
| Locations | 1 site (Delft, South Holland) |
| Trial ID | NCT06508619 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Corsano CardioWatch 287-2, a wearable device designed for continuous blood pressure monitoring, in patients with uncontrolled hypertension. Participants will either be untreated or currently receiving antihypertensive medication, and will undergo a 28-day treatment period where their blood pressure will be tracked using both the Corsano device and a reference device. The goal is to assess the device's ability to accurately measure blood pressure changes during this treatment phase, providing insights into its potential for remote patient monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with uncontrolled hypertension who require initiation or adjustment of antihypertensive medication.
Not a fit: Patients who cannot wear the Corsano CardioWatch due to physical limitations or medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of high blood pressure through continuous remote monitoring, enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using wearable technology for blood pressure monitoring, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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, 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.
Where this trial is running
Delft, South Holland
- Reinier de Graaf Gasthuis — Delft, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Eelko Ronner, PhD — Reinier de Graaf Groep
- Study coordinator: Marjolein Muller, MSc
- Email: marjolein@corsano.com
- Phone: +31658950301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.