Concordance Between Central Blood PRessure dEvices In Nephrology Patients
Key facts
- Who runs it
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 119 people enrolled
- Started
- 26 Apr 2021
- Ended
- 12 Nov 2024
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 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)
- Record updated
- 12 February 2025
- Why it stopped
- lack of funding to enroll all planned participants
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Age 18-80 years old
Who cannot take part
- Ongoing atrial fibrillation
- Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
- Incapacity to give consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- Advanced CKD groupTreatment being tested
Patients with eGFR \< 30 ml/min/1.73m2 not on dialysis
Treatment: 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 groupsTreatment being tested
Patients on hemodialysis or peritoneal dialysis
Treatment: 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 groupTreatment being tested
Patients with BP \> 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR \> 60 ml/min/1.73m2)
Treatment: 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 groupExisting treatment, for comparison
Normotensive patients without any antihypertensive drugs or chronic kidney disease
Treatment: 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)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
- Record updated
- 12 February 2025