Concordance Between Central Blood PRessure dEvices In Nephrology Patients

Hypertension Clinical Trial

— CBP-REIN  

Official title:

Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963880
• Other study ID #: CBP-REIN
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2023
• Source: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Contact: Remi Goupil, MD MSc
• Phone: 1-514-338-2883
• Email: remi.goupil[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular catheterization, which is not possible to perform routinely during the regular follow-up of patients. However, in recent years, devices used to estimate central BP have been designed and approved for clinical use. These devices can determine aortic BP in a non-invasive way using various techniques and algorithms and offer a high degree of precision when compared to invasive measurements of intraaortic BP. On the other hand, certain characteristics specific to the different devices mean that the central BP values obtained may not be interchangeable. It is therefore important to determine the degree of agreement of central BP values obtained using commercially available devices.

This study aims to determine the degree of agreement between central BP measurements obtained using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM, Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA) and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and then derive the central BP using an algorithm. The main differences between these devices lie in this algorithm, or "transfer function,", which is unique to each and the calibration used. All use a brachial cuff to capture the pulse waveform and can easily be used in clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years old

Exclusion Criteria:

• Ongoing atrial fibrillation

• Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)

• Incapacity to give consent

Related Conditions & MeSH terms

• Blood Pressure
• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech)
All participants will have three readings at 1-min interval after a 5-min seated rest with each device. The order in which each device will be tested is randomized.

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central SBP difference	Differences in the central SBP measured by each device	at enrollment (time 0)
Secondary	Brachial SBP difference	Differences in the brachial cuff SBP measured by each device	at enrollment (time 0)
Secondary	Central DBP difference	Differences in the central DBP measured by each device	at enrollment (time 0)
Secondary	Brachial DBP difference	Differences in the brachial cuff DBP measured by each device	at enrollment (time 0)