Digital Hypertension Management for High Blood Pressure

(HrtEx Trial)

Recruiting at 2 trial locations

Overseen By Meg Babakhanian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: ACE-I/ARB, Diuretic

Disqualifiers: Heart failure, ESRD, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital system to help manage high blood pressure. It compares a new mobile health technology, the Digital Hypertension Management System, against usual care to determine which is more effective. People who own a smartphone, have high blood pressure, and take no more than two blood pressure medications may be suitable candidates. Participants must speak English or Spanish and be able to adjust certain medications if needed.

As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance hypertension management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you are able to add or increase the dose of at least two specific types of blood pressure medications. It's best to discuss with the trial team to understand how your current medications fit into the study.

What prior data suggests that the Digital Hypertension Management System is safe for managing high blood pressure?

Research has shown that digital tools for managing high blood pressure are both effective and safe. These tools help individuals control their blood pressure by using devices that automatically monitor and send data, enabling better health management at home.

Although specific safety data is not provided, these systems primarily involve devices for tracking blood pressure. As they are non-invasive and rely on technology rather than medication, they are generally considered safe. In the reviewed studies, users did not report serious side effects.

Overall, digital tools for managing high blood pressure offer a promising and safe method for individuals to manage their condition more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Hypertension Management System because it leverages mobile health technology to help manage high blood pressure in a more interactive and personalized way. Unlike traditional treatments that often rely on medication and occasional doctor visits, this system uses digital tools to provide continuous monitoring and feedback, empowering patients to take more control over their health. Additionally, by integrating technology, it can potentially detect issues earlier and offer tailored advice, which may lead to better overall management of hypertension.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that digital health tools can help manage high blood pressure. In this trial, participants may receive the Digital Hypertension Management System, which studies have linked to improved blood pressure levels, especially in underserved communities. This system encourages regular monitoring with connected devices, enabling more effective home management of the condition. Evidence suggests that using these systems for 6–12 months can greatly improve blood pressure control. Overall, digital tools offer a promising way to help maintain healthy blood pressure levels. ^{1 2 3 4 5}

Who Is on the Research Team?

Paul J Wang, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 30-90 with high blood pressure who own a smartphone and are currently on no more than two blood pressure medications. They must be able to increase the dosage or add at least two types of certain blood pressure drugs, and speak English or Spanish. People can't join if they're pregnant, have specific heart or kidney conditions, recently had a heart attack or stroke, were hospitalized for severe hypertension, or had an organ transplant.

Inclusion Criteria

I am taking 2 or fewer medications for high blood pressure.

I am between 30 and 90 years old.

I can start or increase the dose of at least 2 types of heart medications.

Exclusion Criteria

At the clinical discretion of the investigators

I have not had a heart attack or stroke in the last 6 months.

Enrolled in another clinical study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are assessed for baseline measurements including blood pressure and medication use

1 day

1 visit (in-person)

Treatment

Participants receive either mobile technology intervention or usual care

6 months

Regular monitoring, details not specified

Follow-up

Participants are monitored for changes in blood pressure and medication use

6 months

2 visits (in-person) at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital Hypertension Management System
• Usual Care

Trial Overview The study compares a digital system that helps manage high blood pressure against the usual care methods. Participants will be randomly assigned to one of these two groups in this parallel-design trial to see which is more effective at controlling their condition.

How Is the Trial Designed?

Group I: Mobile Health Technology Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Digital Hypertension Management System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Digital Hypertension Management Solutions for:

• Hypertension management
• Blood pressure monitoring

Approved in European Union as Telemonitoring Systems for:

• Hypertension management
• Cardiovascular risk reduction

Approved in Canada as Connected Blood Pressure Management Systems for:

• Hypertension management
• Blood pressure control

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Santa Clara Valley Medical Center

Collaborator

Trials

17

Recruited

2,400+

The Cooper Health System

Collaborator

Trials

82

Recruited

35,600+

Published Research Related to This Trial

Home blood pressure (BP) telemonitoring significantly enhances patient awareness and management of hypertension, leading to improved BP control rates, especially when combined with self-adjustment based on treatment algorithms.

Telemonitoring that includes active intervention from healthcare professionals not only boosts medication compliance but also increases the likelihood of achieving target BP levels, making it a valuable tool alongside traditional doctor-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. Lee, CJ., Park, S.[2022]

Home blood pressure telemonitoring significantly reduced office blood pressure in hypertensive patients, with an average decrease of 5.64 mm Hg systolic and 2.78 mm Hg diastolic, based on 12 studies involving 4,389 participants.

Patients using telemonitoring had a 31% higher chance of normalizing their blood pressure compared to those receiving usual care, although the technique also led to a slight increase in the use of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Omboni, S., Guarda, A.[2011]

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]

In a study of 7752 patients with primary hypertension, using a digital platform for home blood pressure monitoring and individualized treatment led to a 57% increase in the proportion of patients achieving controlled systolic blood pressure (SBP) after 360 days.

The greatest reduction in SBP was 13.8 mmHg in patients with high SBP, while improvements in blood pressure and other health factors like BMI and smoking were sustained over the 540-day study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics. Willis, M., Darwiche, G., Carlsson, M., et al.[2023]

A digital hypertension self-management program significantly reduced systolic blood pressure (SBP) by an average of 4.8 mm Hg over 12 months for all participants, and by 8.1 mm Hg for those with uncontrolled SBP at baseline, indicating its efficacy in managing hypertension.

Participants with uncontrolled SBP also experienced notable improvements in diastolic blood pressure, weight loss (average of 6.5 lbs), and body mass index (BMI), demonstrating the program's comprehensive impact on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. Wu, J., Napoleone, J., Linke, S., et al.[2023]

The concept of 'Digital Hypertension' aims to enhance blood pressure (BP) management by integrating digital technology, including sensors and machine learning, to monitor BP more frequently and accurately in various situations.

This approach proposes a shift from traditional clinic-based BP readings ('dots') to continuous monitoring through wearable devices ('line'), potentially improving hypertension management and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital hypertension towards to the anticipation medicine. Kario, K.[2023]

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]

In a pilot study involving 19 hypertensive patients over six months, the Health data Monitoring System (HMS) led to an increase in patients reaching their blood pressure goals from 16% to 37%.

The mean home systolic blood pressure decreased significantly from 138.1 mmHg to 130.2 mmHg, suggesting that regular monitoring with HMS can effectively support hypertension management, especially in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. Kishi, T., Usui, H., Nagayoshi, S.[2023]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

Home blood pressure telemonitoring (HBPT) has been shown to improve patient compliance and hypertension control rates, based on randomized controlled trials, although the overall evidence for blood pressure reduction is considered 'moderate'.

Despite the potential of digital health interventions, there is a lack of high-quality evidence regarding the accuracy and safety of mobile applications for hypertension management, indicating that not all available apps are suitable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. Postel-Vinay, N., Bobrie, G., Asmar, R., et al.[2023]

The HERB-DH1 pivotal trial demonstrated that digital therapeutics significantly reduced 24-hour ambulatory blood pressure in patients with hypertension not on medication, with a mean reduction of 2.4 mmHg compared to standard lifestyle modifications alone.

The study involved 390 patients over 12 weeks and found no major safety issues related to the digital therapeutic program, indicating it is a safe and effective non-pharmacological treatment option for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. Kario, K., Nomura, A., Harada, N., et al.[2021]

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]

Citations

1. phti.org phti.org/assessment/digital-hypertension-management-solutions/

Digital Hypertension Management Solutions Digital hypertension management solutions aim to improve patients' self-management and expand access to timely, effective treatment.

2. phti.org phti.org/wp-content/uploads/sites/3/2024/10/PHTI-Digital-Hypertension-Mgmt-Assessment-Report.pdf

Digital Hypertension Management Solutions Specifically, the solutions in this report seek to: (1) encourage regular blood pressure monitoring using connected blood pressure cuffs, (2) automate data ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314696/

Telemonitoring and self-management for digital hypertension ... Telemonitoring and digitally-assisted self-management are increasingly popular in the management of hypertension (1-4). Home telemonitoring ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815070

Digital Health Interventions for Hypertension Management ... These findings suggest that digital health interventions are associated with improved BP levels in populations experiencing health disparities.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537022004424

Digital redesign of hypertension management with practice ... This study provides convincing evidence that the PIA-ICT for hypertension management improves blood pressure control significantly after 6–12 months.