Tailored Drug Titration Using Artificial Intelligence

Last updated: June 27, 2023
Sponsor: Optima Integrated Health
Overall Status: Completed

Phase

N/A

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

optima4BP

Clinical Study ID

NCT04223934
O4BP-001
  • Ages 21-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Home anti-HTN medication therapy doesn't match the electronic health record medicationlist
  • 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 surgeryin 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

Study Design

Total Participants: 164
Treatment Group(s): 1
Primary Treatment: optima4BP
Phase:
Study Start date:
February 18, 2020
Estimated Completion Date:
June 27, 2023

Study Description

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.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

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