Clinical trial NCT04223934: Tailored Drug Titration Using Artificial Intelligence
Official title: ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Optima Integrated Health
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2020-01-13
Enrollment: 164
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, intervention versus control.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in systolic BP [SBP] (mmHg) measured remotely [Time frame: 0 - 6 months]
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Adverse Events [Time Frame: full 12 months]
timeFrame: 6 months and 12 months
measure: Sustained remote SBP Target during observational period [Time Frame: 6 - 12 months (end of study)]
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: Optima Integrated Health
name: Gabriela Voskerician, PhD
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Liviu Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: