Digital Hypertension Management for High Blood Pressure

(HrtEx Trial)

Overseen By Karma Lhamo, MSc

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

Trial Summary

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 data supports the effectiveness of the treatment Digital Hypertension Management System for high blood pressure?

Research shows that using home blood pressure telemonitoring, which is part of digital hypertension management, helps people better control their blood pressure. This approach improves awareness and compliance with treatment, leading to better blood pressure management. ^{1 2 3 4 5}

Is digital hypertension management safe for humans?

Research on digital hypertension management, including telemonitoring systems, shows it is generally safe for humans. Studies have not reported significant adverse events, and patients have shown good compliance with these systems. ^{5 6 7 8 9}

How is the Digital Hypertension Management System different from other treatments for high blood pressure?

The Digital Hypertension Management System is unique because it uses digital technology, like wearable devices and smartphone apps, to continuously monitor blood pressure at home and provide personalized remote treatment. This approach shifts from traditional clinic-based monitoring to a more continuous and individualized management, potentially improving blood pressure control and patient adherence. ^{3 6 10 11 12}

What is the purpose of this trial?

Two arm parallel randomized clinical trial

Research Team

Paul J Wang, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

At the clinical discretion of the investigators

Enrolled in another clinical study

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

A remote hypertension management program clinical algorithm. [2022]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. [2023]

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

Digital hypertension towards to the anticipation medicine. [2023]

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

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

8. England pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]

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

Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]

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

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. [2021]