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Concordance Between Central Blood PRessure dEvices In Nephrology Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05963880
Acronym
CBP-REIN
Enrollment
119
Registered
2023-07-27
Start date
2021-04-26
Completion date
2024-11-12
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Chronic Kidney Disease, Hypertension

Keywords

central blood pressure

Brief 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.

Interventions

DEVICEBrachial 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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Central SBP differenceat enrollment (time 0)Differences in the central SBP measured by each device

Secondary

MeasureTime frameDescription
Brachial SBP differenceat enrollment (time 0)Differences in the brachial cuff SBP measured by each device
Central DBP differenceat enrollment (time 0)Differences in the central DBP measured by each device
Brachial DBP differenceat enrollment (time 0)Differences in the brachial cuff DBP measured by each device

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026