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Digital Hypertension Management for High Blood Pressure
(HrtEx Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPaul J Wang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Must be taking: ACE-I/ARB, Diuretic

Disqualifiers: Heart failure, ESRD, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Two arm parallel randomized clinical trial

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

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 speak English or Spanish.

See 3 more

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

See 6 more

Treatment Details

Interventions

Digital Hypertension Management System (Digital Hypertension Management System)
Usual Care (Other)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Mobile Health TechnologyExperimental Treatment1 Intervention

Group II: Usual CareActive Control1 Intervention

Digital Hypertension Management System is already approved in Canada for the following indications:

Approved in Canada as Connected Blood Pressure Management Systems for:

Hypertension management
Blood pressure control

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Stanford Health CarePalo Alto, CA

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Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+

Santa Clara Valley Medical Center

Collaborator

Trials

Patients Recruited

2,400+

The Cooper Health System

Collaborator

Trials

Patients 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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]