Central Blood Pressure Monitoring Devices for Chronic Kidney Disease

(CBP-REIN Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Central Blood Pressure Monitoring Devices for Chronic Kidney Disease is an effective treatment?

The available research shows that the Mobil-O-Graph device, which is used for central blood pressure monitoring, provides accurate measurements of blood pressure in patients with chronic kidney disease. In studies comparing it to the SphygmoCor device, which is a standard tool for measuring central blood pressure, the Mobil-O-Graph showed similar results. This suggests that it can effectively monitor blood pressure in these patients, which is important for managing their condition. However, the research does not provide direct comparisons to other treatments for chronic kidney disease, so it's unclear how it stacks up against other options. ^{1 2 3 4 5}

What safety data exists for central blood pressure monitoring devices in chronic kidney disease?

The Mobil-O-Graph NG device has been validated according to the European Society of Hypertension criteria, showing high accuracy in both systolic and diastolic pressure measurements, making it suitable for clinical practice. The Microlife WatchBP Office Central has demonstrated high accuracy in a validation study against invasive BP measurement, with limited calibration errors and reliable hypertension diagnosis. These devices have been shown to be safe and effective for use in clinical settings, including for patients with chronic kidney disease. ^{4 6 7 8 9}

Is central blood pressure monitoring a promising treatment for chronic kidney disease?

Yes, central blood pressure monitoring is promising for chronic kidney disease because it provides a more accurate measure of blood pressure, which can help better predict and manage heart and kidney problems. This method is noninvasive, easy to use, and can lead to more reliable diagnoses compared to traditional methods. ^{2 8 10 11 12}

Research Team

Eligibility Criteria

This trial is for kidney disease patients aged 18-80 who can consent to participate. It's not suitable for those with ongoing atrial fibrillation or an arm circumference that doesn't fit the blood pressure cuffs (<18 cm or >50 cm).

Inclusion Criteria

I am between 18 and 80 years old.

Exclusion Criteria

My arm circumference is either less than 18 cm or more than 50 cm.

I currently have atrial fibrillation.

I am unable to understand and give consent for treatment.

Treatment Details

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) (Procedure)

Trial Overview The study tests how well four different devices agree on measuring central blood pressure in a non-invasive way. These are Mobil-o-Graph NG, WatchBP Office, BP+ device, and Oscar 2 with SphygmoCor inside.

Participant Groups

Group I: Hypertension group Experimental Treatment 1 Intervention

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

Group II: Dialysis groups Experimental Treatment 1 Intervention

Patients on hemodialysis or peritoneal dialysis

Group III: Advanced CKD group Experimental Treatment 1 Intervention

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

Group IV: Control group Active Control 1 Intervention

Normotensive patients without any antihypertensive drugs or chronic kidney disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hôpital du Sacré-Coeur de Montréal Montréal, Canada

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

17

Patients Recruited

4,600+

Findings from Research

In a study involving 27 patients undergoing peritoneal dialysis, the Mobil-O-Graph device provided measurements of aortic systolic blood pressure (aSBP), augmentation index (AIx75), and pulse wave velocity (PWV) that were comparable to those obtained from the SphygmoCor device, indicating its reliability.

The strong correlation and acceptable agreement between the two devices suggest that the Mobil-O-Graph is a valid tool for monitoring arterial stiffness and blood pressure in patients receiving peritoneal dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Newly-Introduced Oscillometric Device for the Estimation of Arterial Stiffness Indices in Patients on Peritoneal Dialysis: A Preliminary Validation Study. Vaios, V., Georgianos, PI., Pikilidou, MI., et al.[2019]

The Mobil-O-Graph device showed acceptable agreement with the Sphygmocor device for measuring aortic systolic blood pressure (aSBP) and heart rate-adjusted augmentation index (AIx(75)) in 73 hemodialysis patients, indicating it can be a reliable tool for assessing cardiovascular risk.

However, the Mobil-O-Graph slightly underestimated pulse wave velocity (PWV) compared to Sphygmocor, suggesting that while it is effective for certain measurements, caution may be needed when interpreting PWV results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. Sarafidis, PA., Georgianos, PI., Karpetas, A., et al.[2022]

The Mobil-O-Graph BP device provides a noninvasive estimation of central blood pressure (BP) that is as effective as the established SphygmoCor device, with a mean difference of only -0.6 mmHg between the two devices, indicating high accuracy.

This device simplifies the process by using brachial oscillometric BP waves to estimate central BP in one measurement, making it a convenient alternative for assessing cardiovascular risk in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oscillometric estimation of central blood pressure: validation of the Mobil-O-Graph in comparison with the SphygmoCor device. Weiss, W., Gohlisch, C., Harsch-Gladisch, C., et al.[2022]

Home blood pressure measurement can be beneficial for patients, especially those with chronic kidney disease (CKD), but the accuracy of home sphygmomanometers is often overlooked, which can lead to incorrect readings.

Nephrologists should actively guide patients in using these devices, and there is a need for healthcare systems to cover the costs of validated and accurate home sphygmomanometers to improve blood pressure control in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home sphygmomanometers: what should a nephrologist know? Akpolat, T.[2018]

Both the Seinex SE-9400 and Microlife BP 3AC1-1 blood pressure devices successfully passed the validation process according to the International Protocol of the European Society of Hypertension, demonstrating their reliability for self-measurement.

The average differences in blood pressure readings between the devices and traditional mercury sphygmomanometers were minimal, indicating high accuracy, with differences well within the acceptable limits of <5 mmHg for both systolic and diastolic measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1. Topouchian, JA., El Assaad, MA., Orobinskaia, LV., et al.[2019]

The new generation Mobil-O-Graph 24/48 h ambulatory blood pressure monitor was validated in a study involving 33 individuals, demonstrating high accuracy in measuring systolic and diastolic blood pressure within acceptable limits set by the European Society of Hypertension.

The device achieved over 98% accuracy for systolic pressure within 15 mmHg differences and even better results for diastolic pressure, confirming its reliability for clinical use in monitoring blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria. Franssen, PM., Imholz, BP.[2022]

The Omron M3 Intellisense upper arm blood pressure monitor has been validated for self-measurement in patients with chronic kidney disease (CKD) stages 3-5, based on a study involving 66 patients and following the European Society of Hypertension protocol.

This is the first study to validate an automated oscillometric device specifically for CKD patients, highlighting the need for further research on other devices and the involvement of nephrologists to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population. Akpolat, T., Erdem, E., Aydogdu, T.[2019]

Central blood pressure (CBP) is a more accurate predictor of cardiovascular risk compared to traditional brachial blood pressure (BP), highlighting the need for its assessment in clinical practice.

The Microlife WatchBP Office Central is a noninvasive, automated device that accurately measures CBP and has been shown to improve hypertension diagnosis, reducing the chances of misdiagnosis compared to peripheral BP measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Suitability of a Stand-Alone Oscillometric Central Blood Pressure Monitor: A Review of the Microlife WatchBP Office Central. Verberk, WJ., Cheng, HM., Huang, LC., et al.[2020]

The Mobil O Graph ambulatory blood pressure monitor demonstrated clinical accuracy, achieving a grade B for systolic blood pressure and a grade A for diastolic blood pressure based on assessments from 85 subjects.

The device met the standards set by the Association for the Advancement of Medical Instrumentation, with mean differences of -2 mmHg for both systolic and diastolic readings, indicating it is reliable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A validation of the Mobil O Graph (version 12) ambulatory blood pressure monitor. Jones, CR., Taylor, K., Chowienczyk, P., et al.[2019]

This pilot trial involving 116 adults with advanced chronic kidney disease (CKD G4-5) aims to assess the feasibility and efficacy of managing hypertension using central blood pressure measurements instead of traditional brachial cuff measurements, which may be unreliable in this population.

The study will evaluate the impact of targeting central BP on cardiovascular health and kidney function over 12 months, with primary outcomes including changes in pulse wave velocity and other health metrics, potentially leading to a larger trial in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol. Goupil, R., Nadeau-Fredette, AC., Prasad, B., et al.[2023]

In a study of 2875 patients with chronic kidney disease (CKD) followed for an average of 5.5 years, both elevated brachial and central blood pressure (BP) measurements were linked to a higher risk of cardiovascular disease outcomes.

However, measuring central BP did not provide additional predictive value for cardiovascular outcomes or mortality compared to traditional brachial BP measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central Blood Pressure and Cardiovascular Outcomes in Chronic Kidney Disease. Rahman, M., Hsu, JY., Desai, N., et al.[2023]

The SpaceLabs 90207 ambulatory blood pressure device was validated for use in 85 hemodialysis patients, showing that it provides reliable blood pressure readings, particularly for diastolic pressure, with 96% of readings within 10 mmHg of observer measurements.

While the device performed well overall, it was less accurate at extreme systolic blood pressure ranges, indicating that caution is needed when interpreting readings in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the SpaceLabs 90207 ambulatory blood pressure device for hemodialysis patients. Peixoto, AJ., Gray, TA., Crowley, ST.[2004]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Accuracy of a Newly-Introduced Oscillometric Device for the Estimation of Arterial Stiffness Indices in Patients on Peritoneal Dialysis: A Preliminary Validation Study. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Oscillometric estimation of central blood pressure: validation of the Mobil-O-Graph in comparison with the SphygmoCor device. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Home sphygmomanometers: what should a nephrologist know? [2018]

5. England pubmed.ncbi.nlm.nih.gov

Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Practical Suitability of a Stand-Alone Oscillometric Central Blood Pressure Monitor: A Review of the Microlife WatchBP Office Central. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A validation of the Mobil O Graph (version 12) ambulatory blood pressure monitor. [2019]

10. England pubmed.ncbi.nlm.nih.gov

CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Central Blood Pressure and Cardiovascular Outcomes in Chronic Kidney Disease. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Validation of the SpaceLabs 90207 ambulatory blood pressure device for hemodialysis patients. [2004]