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

Primary Purpose

Hypertension, Chronic Kidney Disease, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
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)
Sponsored by
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring central blood pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital du Sacré-Coeur de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Advanced CKD group

Dialysis groups

Hypertension group

Control group

Arm Description

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

Patients on hemodialysis or peritoneal dialysis

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

Normotensive patients without any antihypertensive drugs or chronic kidney disease

Outcomes

Primary Outcome Measures

Central SBP difference
Differences in the central SBP measured by each device

Secondary Outcome Measures

Brachial SBP difference
Differences in the brachial cuff SBP measured by each device
Central DBP difference
Differences in the central DBP measured by each device
Brachial DBP difference
Differences in the brachial cuff DBP measured by each device

Full Information

First Posted
May 12, 2023
Last Updated
July 25, 2023
Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT05963880
Brief Title
Concordance Between Central Blood PRessure dEvices In Nephrology Patients
Acronym
CBP-REIN
Official Title
Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease, Blood Pressure
Keywords
central blood pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced CKD group
Arm Type
Experimental
Arm Description
Patients with eGFR < 30 ml/min/1.73m2 not on dialysis
Arm Title
Dialysis groups
Arm Type
Experimental
Arm Description
Patients on hemodialysis or peritoneal dialysis
Arm Title
Hypertension group
Arm Type
Experimental
Arm Description
Patients with BP > 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR > 60 ml/min/1.73m2)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Normotensive patients without any antihypertensive drugs or chronic kidney disease
Intervention Type
Device
Intervention Name(s)
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 Description
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.
Primary Outcome Measure Information:
Title
Central SBP difference
Description
Differences in the central SBP measured by each device
Time Frame
at enrollment (time 0)
Secondary Outcome Measure Information:
Title
Brachial SBP difference
Description
Differences in the brachial cuff SBP measured by each device
Time Frame
at enrollment (time 0)
Title
Central DBP difference
Description
Differences in the central DBP measured by each device
Time Frame
at enrollment (time 0)
Title
Brachial DBP difference
Description
Differences in the brachial cuff DBP measured by each device
Time Frame
at enrollment (time 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Remi Goupil, MD MSc
Phone
1-514-338-2883
Email
remi.goupil@umontreal.ca
Facility Information:
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guylaine Marcotte
First Name & Middle Initial & Last Name & Degree
Remi Goupil, MD MSc

12. IPD Sharing Statement

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Concordance Between Central Blood PRessure dEvices In Nephrology Patients

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