Tailored Drug Titration Using Artificial Intelligence

NCT04223934 | Completed DMC

• 1 other identifier: O4BP-001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of Adverse Events [Time Frame: full 12 months]

  6 months and 12 months

• Sustained remote SBP Target during observational period [Time Frame: 6 - 12 months (end of study)]

  6 months

Study Arms (2)

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.

Other: optima4BP

Standard of Care (SOC)

NO INTERVENTION

The treating physician follows usual care practices.

Interventions

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.

optima4BP

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optima Integrated Health: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gabriela Voskerician, PhD

  Optima Integrated Health

  STUDY DIRECTOR

• Liviu Klein, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient blinded to assignment \[intervention versus control\].
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, intervention versus control.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 18, 2020
• Primary Completion: December 30, 2022
• Study Completion: June 27, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)