Tailored Drug Titration Using Artificial Intelligence

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT04223934
• Lead Sponsor: Optima Integrated Health

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-18
• Primary Completion: 2022-12-30
• Status Verified: 2023-03
• Study Completion: 2023-06-27
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in systolic BP [SBP] (mmHg) measured remotely [Time frame: 0 - 6 months]	6 months	optima4BP leads ≥4mmHg of SBP reduction compared to Standard of Care

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events [Time Frame: full 12 months]	6 months and 12 months	Frequency and severity of adverse events (AEs) between baseline and the end of the study.
Sustained remote SBP Target during observational period [Time Frame: 6 - 12 months (end of study)]	6 months	Without optima4BP intervention, the O4BP arm will maintain a ≥4mmHg remote systolic blood pressure (SBP) reduction compared to the SOC arm

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States