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

NCT06508619 | Recruiting

• 1 other identifier: BPTreat
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Blood Pressure

Keywords

Remote monitoring; Photoplethysmography; Blood pressure; Blood pressure lowering medication; Wearable technology; Evaluation

Outcome Measures

Primary Outcomes (3)

• Baseline average BP for both CardioWatch 287-2 and reference

  Baseline average blood pressure per patient and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately.

  Measured in each patient on 1st study day

• Post-treatment average BP for both CardioWatch 287-2 and reference

  Post-treatment average blood pressure and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately.

  Measured in each patient on 28th/last study day

• Average BP change comparing CardioWatch 287-2 and reference

  Absolute systolic and diastolic BP decrease and its standard deviation after change of treatment measured by the Corsano CardioWatch 287-2 after 28 days of monitoring, compared to automatic blood pressure cuff measurements.

  Measured in each patient on 28th/last study day

Secondary Outcomes (2)

• Bland-Altman for CardioWatch 287-2 vs. reference BP

  Measured in each patient on 28th/last study day

• Pearson correlation coefficient between CardioWatch 287-2 vs. reference BP

  Measured in each patient on 28th/last study day

Study Arms (1)

Patients receiving blood pressure lowering medication (uptitration) as standard of care

EXPERIMENTAL

Patients receiving blood pressure lowering medication (uptitration) as standard of care

Device: Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring

Interventions

Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring DEVICE

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

Patients receiving blood pressure lowering medication (uptitration) as standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

RECRUITING

Related Publications (8)

• Michaud GF, Stevenson WG. Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):353-361. doi: 10.1056/NEJMcp2023658. No abstract available.

  PMID: 33503344 BACKGROUND

• Sheppard JP, Lown M, Burt J, Ford GA, Hobbs FDR, Little P, Mant J, Payne RA, McManus RJ; OPTiMISE Investigators. Blood Pressure Changes Following Antihypertensive Medication Reduction, by Drug Class and Dose Chosen for Withdrawal: Exploratory Analysis of Data From the OPTiMISE Trial. Front Pharmacol. 2021 Apr 20;12:619088. doi: 10.3389/fphar.2021.619088. eCollection 2021.

  PMID: 33959004 BACKGROUND

• Meidert AS, Saugel B. Techniques for Non-Invasive Monitoring of Arterial Blood Pressure. Front Med (Lausanne). 2018 Jan 8;4:231. doi: 10.3389/fmed.2017.00231. eCollection 2017.

  PMID: 29359130 BACKGROUND

• Sessler DI, Saugel B. Beyond 'failure to rescue': the time has come for continuous ward monitoring. Br J Anaesth. 2019 Mar;122(3):304-306. doi: 10.1016/j.bja.2018.12.003. Epub 2019 Jan 3. No abstract available.

  PMID: 30770047 BACKGROUND

• McGillion MH, Duceppe E, Allan K, Marcucci M, Yang S, Johnson AP, Ross-Howe S, Peter E, Scott T, Ouellette C, Henry S, Le Manach Y, Pare G, Downey B, Carroll SL, Mills J, Turner A, Clyne W, Dvirnik N, Mierdel S, Poole L, Nelson M, Harvey V, Good A, Pettit S, Sanchez K, Harsha P, Mohajer D, Ponnambalam S, Bhavnani S, Lamy A, Whitlock R, Devereaux PJ; PROTECT Network Investigators. Postoperative Remote Automated Monitoring: Need for and State of the Science. Can J Cardiol. 2018 Jul;34(7):850-862. doi: 10.1016/j.cjca.2018.04.021. Epub 2018 Apr 25.

  PMID: 29960614 BACKGROUND

• Blok S, Piek MA, Tulevski II, Somsen GA, Winter MM. The accuracy of heartbeat detection using photoplethysmography technology in cardiac patients. J Electrocardiol. 2021 Jul-Aug;67:148-157. doi: 10.1016/j.jelectrocard.2021.06.009. Epub 2021 Jul 2.

  PMID: 34256184 BACKGROUND

• Gehring JM, Saeijs-van Niel LC, Ten Bosch-Paniagua LP, Frank MH. Continuous respiration rate monitoring using photoplethysmography technology in patients with Obstructive Sleep Apnea. Under peer review

  BACKGROUND

• Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, Kollias A, Parati G, Asmar R, Pantazis N, Stamoulopoulos A, Asayama K, Castiglioni P, De La Sierra A, Hahn JO, Kario K, McManus RJ, Myers M, Ohkubo T, Shroff SG, Tan I, Wang J, Zhang Y, Kreutz R, O'Brien E, Mukkamala R. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023 Dec 1;41(12):2074-2087. doi: 10.1097/HJH.0000000000003483. Epub 2023 Jun 22.

  PMID: 37303198 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eelko Ronner, PhD

  Reinier de Graaf Groep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolein Muller, MSc

CONTACT

+31658950301; marjolein@corsano.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: July 18, 2024
• Study Start: July 2, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)