Digital Hypertension Management for High Blood Pressure (HrtEx Trial)
Palo Alto (17 mi)Overseen byPaul J Wang, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Stanford University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?Two arm parallel randomized clinical trial
Is the Digital Hypertension Management System a promising treatment for high blood pressure?Yes, the Digital Hypertension Management System is promising because it uses technology to monitor blood pressure more frequently and accurately, helping people manage their blood pressure better at home. It can lead to better long-term control of high blood pressure and improve overall heart health.367911
What safety data exists for digital hypertension management?The safety data for digital hypertension management, including telemonitoring systems and connected blood pressure management systems, is primarily focused on the effectiveness of blood pressure control. Studies have shown that these systems can significantly reduce blood pressure, with reductions in systolic BP ranging from 3.9 to 13.0 mm Hg and diastolic BP from 2.0 to 8.0 mm Hg. Compliance among patients is generally favorable, although healthcare provider compliance is less documented. There is limited robust evidence on secondary outcomes like healthcare utilization and cost. No specific adverse events related to these digital systems were highlighted in the available research.24101112
What data supports the idea that Digital Hypertension Management for High Blood Pressure is an effective treatment?The available research shows that Digital Hypertension Management, which includes home blood pressure telemonitoring, is effective in controlling high blood pressure. Studies indicate that this method helps improve patients' awareness and management of their condition. It has been shown to improve blood pressure control and increase the rate at which patients reach their target blood pressure. Additionally, telemonitoring with active intervention by medical professionals enhances medication adherence. This approach is compared to conventional methods, where blood pressure control rates remain around 50%, suggesting that digital management offers a more effective solution.135810
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, you must be on 2 or fewer current anti-hypertension medications and able to add or increase the dose of at least 2 specific classes of medications.
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.
Exclusion Criteria
My heart's pumping ability is significantly reduced.
I have had a solid organ transplant.
I am on dialysis.
My kidneys are failing (GFR <15).
Treatment Details
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.
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 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford Health CarePalo Alto, CA
Loading ...
Who is running the clinical trial?
Stanford UniversityLead Sponsor
Santa Clara Valley Medical CenterCollaborator
The Cooper Health SystemCollaborator
References
Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]To compare the effectiveness of antihypertensive treatment based on telemonitoring of home blood pressure (BP) and conventional monitoring of office BP.
Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. [2010]We searched five databases (PubMed, CINAHL, PsycINFO, EMBASE, and ProQuest) from 1995 to September 2009 to collect evidence on the impact of blood pressure (BP) telemonitoring on BP control and other outcomes in telemonitoring studies targeting patients with hypertension as a primary diagnosis. Fifteen articles met our review criteria. We found that BP telemonitoring resulted in reduction of BP in all but two studies; systolic BP declined by 3.9 to 13.0 mm Hg and diastolic BP declined by 2.0 to 8.0 mm Hg across these studies. These magnitudes of effect are comparable to those observed in efficacy trials of some antihypertensive drugs. Although BP control was the primary outcome of these studies, some included secondary outcomes such as healthcare utilization and cost. Evidence of the benefits of BP telemonitoring on these secondary outcomes is less robust. Compliance with BP telemonitoring among patients was favorable, but compliance among participating healthcare providers was not well documented. The potential role of BP telemonitoring in the reduction of BP is discussed and suggestions on priority populations that can benefit from this technology are presented.
Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. [2011]Home blood pressure telemonitoring figures among the possible solutions that could help improve blood pressure control of hypertensive patients. To summarize the effectiveness of home blood pressure telemonitoring on blood pressure control from randomized, controlled studies.
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.
The Role of Home Blood Pressure Telemonitoring for Blood Pressure Control. [2022]Despite improvements in hypertension awareness and treatment, the blood pressure (BP) control rate still remains at around 50%. One of the major determinants of low BP control results from therapeutic inertia of the physician and suboptimal compliance of the patients. Home BP self-measurement and monitoring improves patients' awareness and helps the management of hypertension. Recent technological advances are allowing for accurate measurement and telemonitoring of home BP, with a number of randomized clinical trials demonstrating the efficacy of telemonitoring for BP control. Home BP telemonitoring combined with self-adjustment based on prespecified treatment algorithms has been shown to improve BP control. Additionally, telemonitoring with active intervention by medical professionals has been shown to improve drug compliance and increase the target BP achievement rate. Although nothing can replace the tried and tested doctor-patient relationship in the office, telemonitoring of home BP will be an important tool for treating hypertension in the future.
[Telemonitoring and eHealth for arterial hypertension : Status quo and perspectives]. [2021]Home blood pressure monitoring in combination with cointerventions can contribute to a better blood pressure control. More complex telemonitoring projects have shown promising initial results in studies in primary care and also in certain patient groups (e.g. pregnant women). The integration into the clinical routine is of crucial importance because "stand-alone" solutions have yet to show convincing effects on blood pressure. The new German Digital Care Act (Digitale-Versorgung-Gesetz, DVG) provides a framework to introduce, validate and prescribe digital applications in routine care financed by the Statutory Health Insurance, when positive effects on care have been confirmed and they are listed in the register of the digital healthcare applications (Verzeichnis der digitalen Gesundheitsanwendungen, DiGA).
Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. [2021]Digital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication.
A remote hypertension management program clinical algorithm. [2022]Hypertension is the leading risk factor for death, affecting over one billion people worldwide, yet control rates are poor and stagnant. We developed a remote hypertension management program that leverages digitally transmitted home blood pressure (BP) measurements, algorithmic care pathways, and patient-navigator communications to aid patients in achieving guideline-directed BP goals.
Real-world long-term effects on blood pressure and other cardiovascular risk factors for patients in digital therapeutics. [2023]Hypertension is a leading causeof premature death worldwide and a major public health problem. This study investigated the long-term effects (>1 year) of digital hypertension monitoring by home blood pressure (HBP) measurements in combination with individualized remote treatment via a Swedish Digital Therapeutics platform in a large patient population.
Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. [2023]Digital health programs that incorporate frequent blood pressure (BP) self-monitoring and support for behavior change offer a scalable solution for hypertension management.
Digital hypertension towards to the anticipation medicine. [2023]"Digital Hypertension" is a new research field proposed by the Japanese Society of Hypertension that integrates digital technology into hypertension management and proactively promotes research activities. This novel approach includes the development of new technologies for better BP management, such as sensors for detecting environmental factors that affect BP, information processing, and machine learning. To facilitate "Digital Hypertension," a more sophisticated BP monitoring system capable of measuring an individual's BP more frequently in various situations would be required. With the use of these technologies, hypertension management could shift from the current "dots" management based on office BP readings during clinic visits to a "line" management system based on seamless home BP or individual BP data taken by a wearable BP monitoring device. DTx is the innovation to change hypertension management from "dots" to "line", completely achieved by wearable BP.
A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. [2023]In Japan, a hypertension treatment aid application (CureApp Co., Ltd.) with educational content on hypertension was the first in the world to show significant blood pressure (BP) reduction in hypertensive patients in 2021. Omron Healthcare Corporation and I developed the Health data Monitoring System (HMS) without educational content, which allows patients to check their home BP values periodically and allows physicians to check their home BP data before the hospital visit. As a pilot study, nineteen patients with hypertension used HMS for six months. The percentage of patients achieving their antihypertensive goal increased from 16% to 37%. Mean home systolic BP decreased from 138.1 ± 11.8 mmHg to 130.2 ± 7.8 mmHg. The increase in number of home BP measurements was significantly associated with the amount of homed systolic BP reduction in men. In conclusion, HMS without educational content may be an adjunct to hypertension treatment.