Concordance Between Central Blood PRessure dEvices In Nephrology Patients
NCT ID: NCT05963880
Last Updated: 2025-02-12
Study Results
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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TERMINATED
NA
119 participants
INTERVENTIONAL
2021-04-26
2024-11-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Advanced CKD group
Patients with eGFR \< 30 ml/min/1.73m2 not on dialysis
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.
Dialysis groups
Patients on hemodialysis or peritoneal dialysis
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.
Hypertension group
Patients with BP \> 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR \> 60 ml/min/1.73m2)
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.
Control group
Normotensive patients without any antihypertensive drugs or chronic kidney disease
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Arm circumference incompatible with the blood pressure cuffs for all devices (\<18 cm or \> 50 cm)
* Incapacity to give consent
18 Years
80 Years
ALL
Yes
Sponsors
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
OTHER
Responsible Party
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Locations
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Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CBP-REIN
Identifier Type: -
Identifier Source: org_study_id
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