University of California San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT04223934
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.
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Notify Me21 year–80 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care [Time frame: 0 - 6 months].
Time frame: 12 months
Incidence of adverse events (AEs) during the course of the study [12 months].
Time frame: 12 months
Without o4BP intervention, the o4BP arm will maintain a remote systolic blood pressure (SBP) reduction compared to the SOC arm.
Optima Integrated Health
Industry
ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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