Remote Monitoring for High Blood Pressure

Overseen By Wendi Mitchell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Michigan Cancer Center

Must be taking: Bevacizumab

Disqualifiers: Unable to understand English, hospitalized, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a cellular-enabled blood pressure cuff used at home can manage high blood pressure more effectively than usual care for cancer patients taking bevacizumab, a common cancer treatment. The study will compare two groups: one using the smart blood pressure cuff and a control group receiving standard care. It seeks participants who are current patients at specific cancer centers, are receiving bevacizumab, and can measure their blood pressure at home. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cellular enabled blood pressure cuff is safe for remote monitoring?

Research has shown that using a blood pressure cuff with cellular technology is generally safe. Studies have found that these devices effectively manage high blood pressure without causing major issues. For instance, one study demonstrated that remote monitoring with these cuffs improved patients' blood pressure control. This indicates that the cuffs are effective at tracking blood pressure, which is crucial for managing high blood pressure.

Moreover, a program using a similar remote blood pressure device successfully recorded blood pressure changes across a diverse population. This suggests that the device can accurately measure blood pressure without causing harm.

Overall, research suggests that cellular-enabled blood pressure cuffs are well-tolerated and do not pose any major safety concerns for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cellular-enabled blood pressure cuff because it offers a new way to manage high blood pressure by allowing remote monitoring. Unlike traditional methods that require in-person visits for blood pressure checks, this smart cuff uses cellular technology to transmit data directly to healthcare providers. This continuous, real-time monitoring can lead to more timely adjustments in treatment, potentially improving patient outcomes and convenience.

What evidence suggests that this remote monitoring method is effective for high blood pressure?

This trial will compare the effectiveness of a smart blood pressure cuff with a cellular connection to standard care. Research has shown that using a blood pressure cuff with a cellular connection can effectively manage high blood pressure. In one study, participants using remote monitoring saw their top blood pressure number drop by an average of 7.3 points, while those with more severe high blood pressure experienced a decrease of 16.7 points. Another study found that when individuals checked their blood pressure at home and received additional medical support, their blood pressure improved significantly. Overall, using these smart cuffs can help more people reach their blood pressure goals, with one study showing a 70% increase in patients hitting their target numbers. These tools work well, especially when combined with extra support, to manage high blood pressure successfully. ^{1 2 6 7 8}

Who Is on the Research Team?

David Shalowitz

Principal Investigator

West Michigan Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients with high blood pressure who are being treated with bevacizumab. It's designed to see if monitoring blood pressure remotely can help manage hypertension better and improve patient satisfaction.

Inclusion Criteria

I am currently being treated with bevacizumab.

Participant is willing and able to provide written informed consent

Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center

Exclusion Criteria

Participants are unable to obtain blood pressure readings at home

I cannot understand English.

I am currently in the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote blood pressure monitoring or usual care while undergoing therapy with bevacizumab

12 weeks

Remote monitoring with potential virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Cellular enabled blood pressure cuff

Trial Overview The study compares two groups: one uses a cellular-enabled blood pressure cuff for remote monitoring, while the other group follows usual care practices without remote technology.

How Is the Trial Designed?

Group I: Smart Cuff Group Active Control 1 Intervention

Smart blood pressure cuff

Group II: Control Group Placebo Group 1 Intervention

Standard of care

Cellular enabled blood pressure cuff is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell cancer
• Epithelial ovarian, fallopian tube or primary peritoneal cancer
• Cervical cancer

Approved in United States as Avastin for:

• Metastatic colorectal cancer
• Non-squamous non-small cell lung cancer
• Glioblastoma
• Metastatic renal cell carcinoma
• Cervical cancer
• Epithelial ovarian, fallopian tube or primary peritoneal cancer

Approved in Canada as Mvasi for:

• Metastatic colorectal cancer
• Non-squamous non-small cell lung cancer
• Glioblastoma
• Metastatic renal cell carcinoma
• Cervical cancer
• Epithelial ovarian, fallopian tube or primary peritoneal cancer

Who Is Running the Clinical Trial?

West Michigan Cancer Center

Lead Sponsor

Trials

2

Recruited

170+

Veta Health

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

Remote monitoring of blood pressure using telemedicine technology can significantly improve the management of arterial hypertension, leading to better control of blood pressure levels in patients.

Implementing remote monitoring in Russia has shown promising results in achieving target blood pressure levels, which could ultimately reduce emergency care visits and lower the risk of serious cardiovascular events like strokes and heart attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realities and prospects of remote blood pressure monitoring in hypertensive patients. Boytsov, SA.[2019]

Ambulatory blood pressure monitoring (ABPM) is recommended as the gold standard for measuring blood pressure outside of the office, as it provides a more accurate assessment of cardiovascular risk compared to office measurements.

Home blood pressure monitoring (HBPM) is a valid alternative when ABPM is not feasible, and it is particularly useful for patients on antihypertensive medication to detect white-coat and masked hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of ambulatory blood pressure monitoring and home blood pressure monitoring for the diagnosis and management of hypertension in the US: an up-to-date review. Cepeda, M., Pham, P., Shimbo, D.[2023]

A study involving 236 hypertensive patients found that antihypertensive treatment guided by telemonitoring of home blood pressure was as effective as traditional office-based monitoring in reducing systolic daytime blood pressure over 6 months.

Both groups experienced significant decreases in blood pressure, with the telemonitoring group showing a reduction of -11.9 mmHg compared to -9.6 mmHg in the control group, indicating that home monitoring can be a viable alternative for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. Madsen, LB., Kirkegaard, P., Pedersen, EB.[2008]

Out-of-office blood pressure monitoring, including home and ambulatory methods, provides more accurate and comprehensive data for managing hypertension compared to traditional office measurements, helping to identify conditions like white-coat and masked hypertension.

Home blood pressure monitoring has been shown to improve long-term control of hypertension by enhancing patient adherence to treatment, and it is recommended by guidelines in multiple countries for confirming hypertension diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for home blood pressure monitoring in Latin American countries: A Latin American Society of Hypertension position paper. Villar, R., Sánchez, RA., Boggia, J., et al.[2021]

A remote hypertension management program was developed that uses home blood pressure monitoring and algorithmic care pathways, showing promise in helping patients achieve better blood pressure control.

The program involves non-licensed patient navigators working under the supervision of healthcare professionals, allowing for personalized medication adjustments based on patient-specific characteristics, which could enhance scalability and effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. Nichols, H., Cannon, CP., Scirica, BM., et al.[2022]

The VASOTENS Registry analyzed data from 1200 participants using 24-hour ambulatory blood pressure monitoring to assess cardiovascular risk factors, revealing that older individuals and those with hypertension had higher blood pressure and vascular stiffness.

The study found that women had lower blood pressure but higher measures of vascular stiffness (PWV and AIx), indicating that ambulatory pulse wave analysis could be a useful tool for evaluating vascular health in individuals at risk for cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure and arterial stiffness web-based telemonitoring in patients at cardiovascular risk. First results of the VASOTENS (Vascular health ASsessment Of The hypertENSive patients) Registry. Omboni, S., Posokhov, I., Parati, G., et al.[2021]

Blood pressure (BP) telemonitoring significantly reduces both systolic BP (by 3.9 to 13.0 mm Hg) and diastolic BP (by 2.0 to 8.0 mm Hg), showing effects comparable to some antihypertensive medications, based on a review of 15 studies.

While BP control was the main focus, the evidence for BP telemonitoring's impact on secondary outcomes like healthcare utilization and costs was less conclusive, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. AbuDagga, A., Resnick, HE., Alwan, M.[2010]

The study demonstrated that an intensive mobile blood pressure management strategy is feasible for acute ischemic stroke patients, with 95% of participants completing the final visit and high adherence to blood pressure measurement criteria (91% in the intensive group).

No adverse events related to the trial procedures were reported, indicating that the remote monitoring approach is safe for patients, although improvements to the device are needed before larger trials can be conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. Kim, BJ., Park, JM., Park, TH., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353537/

Remote Patient Monitoring Is Associated with Improved ... Systolic blood pressure improved by 7.3 mmHg for all patients and 16.7 mmHg for stage 2 HTN. There was improvement in mean arterial pressure ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11549951/

The Impact of Wearable Technologies on Blood Pressure ... This systematic review and meta-analysis evaluated the impact of wearable technologies on blood pressure control in hypertensive patients.

3. nature.com nature.com/articles/s41440-024-01981-4

Self-measurement of blood pressure at home using a cuff ... Our results demonstrated a beneficial effect of HBPM in reducing BP, particularly when used in conjunction with telemonitoring or additional medical support.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25003126

Clinical and Engagement Results of a Nationwide ... There was a 70% relative increase in the number of patients at goal BP at follow-up (36.6% vs 21.5%; P < 0.001). Results among rural/underserved patients were ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.034031

Implementation of a Cell‐Enabled Remote Blood Pressure ... A cell‐enabled postpartum remote BP monitoring program was successful in uniformly monitoring BP and capturing hypertension among a diverse, safety‐net ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2764578

Effect of Smartphone-Enabled Health Monitoring Devices ... This randomized clinical trial of 200 patients found that there was no statistically significant difference in regulated blood pressure between groups at 12 ...

7. nature.com nature.com/articles/s41467-023-40763-3

Thin, soft, wearable system for continuous wireless ... Initial trials on 87 volunteers and clinical tracking of two hypertension individuals prove the capability of the TSMS as a reliable BP ...

8. news-medical.net news-medical.net/news/20250808/New-wearable-device-offers-real-time-blood-pressure-monitoring.aspx

New wearable device offers real-time blood pressure ... Simply attaching it to the wrist allows real-time monitoring of blood pressure changes, eliminating the inconvenience of having to measure blood ...