Concordance Between Central Blood PRessure dEvices In Nephrology Patients

NCT ID: NCT05963880

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2024-11-12

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Chronic Kidney Disease Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Advanced CKD group

Patients with eGFR \< 30 ml/min/1.73m2 not on dialysis

Group Type EXPERIMENTAL

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)

Intervention Type DEVICE

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.

Dialysis groups

Patients on hemodialysis or peritoneal dialysis

Group Type EXPERIMENTAL

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)

Intervention Type DEVICE

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.

Hypertension group

Patients with BP \> 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR \> 60 ml/min/1.73m2)

Group Type EXPERIMENTAL

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)

Intervention Type DEVICE

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.

Control group

Normotensive patients without any antihypertensive drugs or chronic kidney disease

Group Type ACTIVE_COMPARATOR

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)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CBP-REIN

Identifier Type: -

Identifier Source: org_study_id

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