HypertensionCBP-REINNCT05963880
Concordance Between Central Blood PRessure dEvices In Nephrology Patients
A study testing 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) in people with Hypertension and Chronic Kidney Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Chronic Kidney Disease, Blood Pressure
- What is being 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)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2021to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
Who cannot join
- Ongoing atrial fibrillation
- Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
- Incapacity to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
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
- Being 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)
- Keywords
- central blood pressure
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced CKD group | Experimental | Patients with eGFR < 30 ml/min/1.73m2 not on dialysis Receives: 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 Receives: 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) Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central SBP difference
Differences in the central SBP measured by each device
Measured: at enrollment (time 0)
Secondary outcomes (3)
Brachial SBP difference
Differences in the brachial cuff SBP measured by each device
Measured: at enrollment (time 0)
Central DBP difference
Differences in the central DBP measured by each device
Measured: at enrollment (time 0)
Brachial DBP difference
Differences in the brachial cuff DBP measured by each device
Measured: at enrollment (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start26 Apr 2021
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Why it stopped: lack of funding to enroll all planned participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963880
- Sponsor's protocol ID
- CBP-REIN
- Acronym
- CBP-REIN
- Status last verified
- Feb 2025
- First submitted
- 12 May 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
- ClinicalTrials.gov ID
- NCT05963880
- Acronym / sponsor ID
- CBP-REIN / CBP-REIN
- Conditions
- Hypertension, Chronic Kidney Disease, Blood Pressure
- Keywords
- central blood pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding to enroll all planned participants
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Advanced CKD group | Experimental | 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)Patients with eGFR < 30 ml/min/1.73m2 not on dialysis |
| Dialysis groups | Experimental | 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)Patients on hemodialysis or peritoneal dialysis |
| Hypertension group | Experimental | 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)Patients with BP > 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR > 60 ml/min/1.73m2) |
| Control group | Active comparator | 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)Normotensive patients without any antihypertensive drugs or chronic kidney disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years old
Key exclusion criteria (3 listed)
- Ongoing atrial fibrillation
- Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
- Incapacity to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Advanced CKD group, Control group, Dialysis groups, Hypertension group |
Primary outcome
Central SBP difference
Time frame: at enrollment (time 0)
Differences in the central SBP measured by each device
3 secondary outcomes
Brachial SBP difference
Time frame: at enrollment (time 0)
Central DBP difference
Time frame: at enrollment (time 0)
Brachial DBP difference
Time frame: at enrollment (time 0)
Results and safety
The study was stopped early (reason given: lack of funding to enroll all planned participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Hypertension and Chronic Kidney Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding to enroll all planned participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central SBP difference (time frame: at enrollment (time 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.