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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP), a clinical decision support system for hypertension (HTN) treatment optimization to standard of care in patients with essential HTN.
Nearly 34 million Americans have their blood pressure (BP) uncontrolled. Hypertension (HTN) claims 1000 deaths every day. Despite medication and life-style management, the cost of HTN associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital costs, with >135 million Emergency Department (ED) visits.
Uncontrolled HTN for even a few weeks is associated with increased risk for acute cardiovascular (CVD) events [stroke, heart failure (HF), myocardial infarction (MI)] and death. Medication treatment optimization to BP goal reduces the incidence of stroke by 35-40%, HF by up to 64%, and MI by 15-25%.
optima-for-blood pressure [optima4BP] transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optima4BP | Experimental | Treating physicians receive periodic (every 5-8 weeks) medication treatment recommendations intended to optimize the current patient treatment. The recommendations are generated based on periodic remote data collected from the patient and from the Electronic Health Record. The analysis of the data allows assessment of the patient's response to current treatment and need for a treatment optimization. If a treatment optimization is needed, one is generated and sent to the treating physician for consideration. |
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| Standard of Care (SOC) | No Intervention | The treating physician follows usual care practices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optima4BP | Other | optima4BP establishes a "no gaps" computational framework in determining the most effective treatment change that can optimize a patient's HTN management towards BP Target. All possible drug combination options available through the 16 anti-HTN drug classes and subclasses are quantitatively evaluated in the context of 5 actions: add a drug, remove a drug, replace a drug, increase a drug dose, and decrease a drug dose. The pharmacological intervention efficacy ranking is computed and the highest ranked treatment recommendation is selected for consideration by the treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in systolic BP [SBP] (mmHg) measured remotely [Time frame: 0 - 6 months] | optima4BP leads ≥4mmHg of SBP reduction compared to Standard of Care | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Time Frame: full 12 months] | Frequency and severity of adverse events (AEs) between baseline and the end of the study. | 6 months and 12 months |
| Sustained remote SBP Target during observational period [Time Frame: 6 - 12 months (end of study)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Voskerician, PhD | Optima Integrated Health | Study Director |
| Liviu Klein, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
Individual patient data will not be made available to other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2024 | |
| Reset | Sep 4, 2024 | |
| Release | Aug 28, 2025 | |
| Reset | Aug 28, 2025 | |
| Release | Apr 10, 2026 | |
| Reset | Apr 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2024 | Sep 4, 2024 | |||
| Aug 28, 2025 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized, intervention versus control.
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Patient blinded to assignment [intervention versus control].
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Without optima4BP intervention, the O4BP arm will maintain a ≥4mmHg remote systolic blood pressure (SBP) reduction compared to the SOC arm |
| 6 months |
| Aug 28, 2025 |
| Apr 10, 2026 | Apr 13, 2026 |