HypertensionNCT04223934
Tailored Drug Titration Using Artificial Intelligence
A study testing optima4BP in people with Hypertension, run by Optima Integrated Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- optima4BP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- optima4BP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optima4BPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: optima4BP |
| Standard of Care (SOC) | No intervention | The treating physician follows usual care practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months]
SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care [Time frame: 0 - 6 months].
Measured: 6 months
Secondary outcomes (2)
Incidence of Adverse Events [Time Frame: Full 12 Months]
Incidence of adverse events (AEs) during the course of the study [12 months].
Measured: 12 months
SBP at12 Months (End of Study)]
Without o4BP intervention, the o4BP arm will maintain a remote systolic blood pressure (SBP) reduction compared to the SOC arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start18 Feb 2020
- Primary completion30 Dec 2022
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, intervention versus control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optima Integrated Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gabriela Voskerician, PhD, Study director, Optima Integrated HealthLiviu Klein, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223934
- Sponsor's protocol ID
- O4BP-001
- Other IDs
- R44HL149428
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2020
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
- ClinicalTrials.gov ID
- NCT04223934
- Acronym / sponsor ID
- O4BP-001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Optima Integrated HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, intervention versus control.
| Arm | Type | Receives |
|---|---|---|
| optima4BP | Experimental | Other: optima4BPTreating 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. |
| Standard of Care (SOC) | No intervention | –The treating physician follows usual care practices. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optima4BPoptima4BP 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. | Other | optima4BP |
Primary outcome
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].
2 secondary outcomes
Incidence of Adverse Events [Time Frame: Full 12 Months]
Time frame: 12 months
SBP at12 Months (End of Study)]
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual patient data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Voskerician, PhD study director
Optima Integrated Health
Liviu Klein, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optima4BP in people with Hypertension, run by Optima Integrated Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.