Central Blood Pressure Monitoring Devices for Chronic Kidney Disease

(CBP-REIN Trial)

No longer recruiting at 1 trial location

Overseen By Remi Goupil, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Atrial fibrillation, Arm size, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines four devices that measure central blood pressure in individuals with different health conditions. The goal is to compare the accuracy of these devices. Participants will have their blood pressure checked using all four devices, which involve a simple arm cuff and are easy to use. Suitable candidates include those with advanced chronic kidney disease, high blood pressure, or those on dialysis. Participants should not have ongoing atrial fibrillation, and their arm size must fit the devices’ cuffs. As an unphased trial, this study allows participants to contribute to research that could enhance blood pressure monitoring for various health conditions.

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 prior data suggests that these central blood pressure monitoring devices are safe for use in patients with chronic kidney disease?

Research shows that central blood pressure monitoring devices are safe to use. Tests have confirmed that the Mobil-O-Graph NG device performs as well as other trusted methods, accurately measuring blood pressure without invasive procedures.

The Oscar 2 device offers comfort and reliability, enabling easy 24-hour blood pressure monitoring. Patients generally find it user-friendly. Both devices are frequently used in medical settings, indicating their trustworthiness and safety. Being non-invasive, they do not enter the body, enhancing their safety.

Overall, evidence suggests that these central blood pressure monitoring devices are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to monitor blood pressure in people with chronic kidney disease (CKD). Unlike traditional methods that focus on brachial blood pressure measured at the arm, this trial includes devices that can measure central blood pressure, which may provide more accurate insights into cardiovascular health. Central blood pressure is closer to the heart and may be a better predictor of heart disease risk, a common concern for CKD patients. By using advanced devices like the Mobil-o-Graph NG, WatchBP Office, BP+, and Oscar 2 with SphygmoCor, the trial aims to refine our understanding of blood pressure's role in CKD management and possibly improve patient outcomes.

What evidence suggests that these central blood pressure monitoring devices are effective for chronic kidney disease?

This trial will evaluate the effectiveness of various central blood pressure monitoring devices for different patient groups. Studies have shown that devices like the Mobil-O-Graph and the Microlife WatchBP Office provide accurate central blood pressure readings. These readings are crucial because they reflect the pressure near the heart, which is important for patients with conditions like chronic kidney disease. The Mobil-O-Graph, for example, matches more invasive central pressure measurements accurately without needing a catheter. Similarly, the Microlife WatchBP Office effectively estimates central systolic blood pressure. These devices use special calculations to convert readings from a regular arm cuff into central blood pressure data, making them easy to use and reliable for everyday monitoring. Participants in this trial will be assigned to groups such as the Advanced CKD group, Hypertension group, Control group, or Dialysis groups to assess the performance of these devices across various conditions. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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).

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Measurement

Participants undergo baseline measurements of central and brachial blood pressure using four different devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any discrepancies in blood pressure measurements across devices

4 weeks

What Are the Treatments Tested in This Trial?

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)

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.

How Is the Trial Designed?

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

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

Recruited

4,600+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-kidney-diseases-3-2021-c3f6a

Central Blood Pressure Monitoring Devices for Chronic ... The available research shows that the Mobil-O-Graph device, which is used for central blood pressure monitoring, provides accurate measurements of blood ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03058874

Effect of Dry-weight Probing Guided by Lung-Ultrasound ... The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to monitor central aortic pressure and indices of vascular resistance ...

3. researchgate.net researchgate.net/publication/221841244_Ambulatory_Blood_Pressure_Monitoring_An_Invaluable_Tool_Comes_of_Age_for_Patients_with_Chronic_Kidney_Disease

Ambulatory Blood Pressure Monitoring: An Invaluable Tool ... How reliable is office assessed blood pressure in chronic kidney disease (CKD) patients and kidney transplant (KTx) recipients is yet to be determined, as ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/20543581231172407

CENtral blood pressure Targeting: a pragmatic ... This is the first trial to evaluate the feasibility and efficacy of using central BP to manage hypertension in advanced CKD, paving the way to a future large- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865074/

A Review of the Microlife WatchBP Office Central - PMC Comparison between Mobil-O-Graph and the SphygmoCor device for central systolic blood pressure estimation: consensus is required for 'validation protocols ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22561735/

validation of the Mobil-O-Graph in comparison with ... Oscillometric noninvasive estimation of central BP with the Mobil-O-Graph BP device is as effective as using the well-established SphygmoCor applanation ...

7. suntechmed.com suntechmed.com/bp-products/ambulatory-blood-pressure-monitoring/oscar-2-ambulatory-blood-pressure-monitor

Oscar 2 Ambulatory Blood Pressure Monitor The Oscar 2 Ambulatory Blood Pressure Monitor delivers a patient-focused solution to 24 hour abpm with unsurpassed comfort, data reliability and confidence.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20658764/

Evaluation of the Mobil-O-Graph new generation ABPM ... We report on the validation of the new generation Mobil-O-Graph 24/48 h ambulatory blood pressure monitor according to the criteria of the European Society ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/K964235.pdf

Graph Blood Pressure Monitor, Model ABP Control Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care ...