Remote Monitoring for High Blood Pressure

Overseen by David Shalowitz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: West Michigan Cancer Center

Must be taking: Bevacizumab

Disqualifiers: Unable to understand English, hospitalized, others

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.

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 data supports the effectiveness of the treatment Cellular enabled blood pressure cuff for high blood pressure?

Research shows that remote monitoring of blood pressure using telemonitoring technology can help reduce blood pressure levels, similar to some blood pressure medications. This approach can improve blood pressure control and reduce the risk of heart-related issues. ^{1 2 3 4 5}

Is remote monitoring for high blood pressure safe for humans?

Remote monitoring for high blood pressure, using devices like a blood pressure cuff that sends data to healthcare providers, has been studied and found to be safe. In a study with stroke patients, no adverse events related to the trial procedures were reported, indicating that the process is generally safe for human use. ^{1 4 5 6 7}

How does the treatment 'Cellular enabled blood pressure cuff' differ from other treatments for high blood pressure?

The cellular enabled blood pressure cuff is unique because it allows for remote monitoring of blood pressure, enabling patients to measure their blood pressure at home and transmit the data digitally to healthcare providers. This approach can improve adherence to treatment and help achieve better blood pressure control compared to traditional in-office measurements. ^{1 2 4 5 8}

Research Team

David Shalowitz

Principal Investigator

West Michigan Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cellular enabled blood pressure cuff (Device)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. [2010]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

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

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

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]

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

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. [2020]

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

A remote hypertension management program clinical algorithm. [2022]

6. England 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. [2023]

7. United States 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. [2021]

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

Recommendations for home blood pressure monitoring in Latin American countries: A Latin American Society of Hypertension position paper. [2021]