Concordance Between Central Blood PRessure dEvices In Nephrology Patients

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension, Chronic Kidney Disease, Blood Pressure

Intervention / Treatment
-----------------
* 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)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced CKD group<br>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)<br>* 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.<br>|
| Experimental: Dialysis groups<br>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)<br>* 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.<br>|
| Experimental: Hypertension group<br>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)<br>* 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.<br>|
| Active Comparator: Control group<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central SBP difference | Differences in the central SBP measured by each device | at enrollment (time 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial SBP difference | Differences in the brachial cuff SBP measured by each device | at enrollment (time 0) | 
| Central DBP difference | Differences in the central DBP measured by each device | at enrollment (time 0) | 
| Brachial DBP difference | Differences in the brachial cuff DBP measured by each device | at enrollment (time 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central blood pressure