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Completed

NCT Number: NCT04223934

Tailored Drug Titration Using Artificial Intelligence

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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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Two or more blood pressure (BP) readings of ≥ 140/90 mmHg during UCSF primary care or cardiology office visits within the last 12 months
  • Therapy with medications from at least 1 anti-HTN pharmacological agents at the time of the last office visit
  • At least minimally "tech-savvy" defined as Ownership of a compatible smartphone and Ability to access the internet
  • Active Electronic Health Record MyChart account

Exclusion criteria

  • Home anti-HTN medication therapy doesn't match the electronic health record medication list
  • Anti-HTN medication therapy changed within 30 days prior to enrollment
  • Inability to operate a BP cuff
  • Incompatible smartphone device (Galaxy S5 Android 5.0)
  • Less than minimally "tech-savvy" defined as Inability to use the Internet
  • Non-compliance with medical follow-up (>3 "no shows" in the previous 12 months)
  • Planned coronary revascularization in the next 12 months
  • Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
  • GFR < 30 (CKD stage IV/ V)
  • Treating physician rules out the patient due to superseding health management concerns
  • Treating physician rules out the patient due to other concerns

Treatment and study plan

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.

Primary outcomes

  1. Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months]

    Time frame: 6 months

    SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care [Time frame: 0 - 6 months].

Secondary outcomes

  1. Incidence of Adverse Events [Time Frame: Full 12 Months]

    Time frame: 12 months

    Incidence of adverse events (AEs) during the course of the study [12 months].

  2. SBP at12 Months (End of Study)]

    Time frame: 12 months

    Without o4BP intervention, the o4BP arm will maintain a remote systolic blood pressure (SBP) reduction compared to the SOC arm.

Sponsors and collaborators

Lead sponsor

Optima Integrated Health

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of California, San Francisco

Registry information

Official study title

ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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