Concordance Between Central Blood PRessure dEvices In Nephrology Patients

NCT05963880 | Terminated

• 1 other identifier: CBP-REIN
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Chronic Kidney Disease; Blood Pressure

Keywords

central blood pressure

Outcome Measures

Primary Outcomes (1)

• Central SBP difference

  Differences in the central SBP measured by each device

  at enrollment (time 0)

Secondary Outcomes (3)

• Brachial SBP difference

  at enrollment (time 0)

• Central DBP difference

  at enrollment (time 0)

• Brachial DBP difference

  at enrollment (time 0)

Study Arms (4)

Advanced CKD group

EXPERIMENTAL

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

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)

Dialysis groups

EXPERIMENTAL

Patients on hemodialysis or peritoneal dialysis

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)

Hypertension group

EXPERIMENTAL

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

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)

Control group

ACTIVE COMPARATOR

Normotensive patients without any antihypertensive drugs or chronic kidney disease

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)

Interventions

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) 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.

Advanced CKD group; Control group; Dialysis groups; Hypertension group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age 18-80 years old

You may not qualify if:

• Ongoing atrial fibrillation
• Arm circumference incompatible with the blood pressure cuffs for all devices (\<18 cm or \> 50 cm)
• Incapacity to give consent

Sponsors & Collaborators

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

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J1C5, Canada

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

Sphygmomanometers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: July 27, 2023
• Study Start: April 26, 2021
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

CA (1)