HypertensionARTERYNCT03397524
Tailored Drug Titration Through Artificial Intelligence
A study testing optima4BP in people with Hypertension, run by Optima Integrated Health at 1 site in United States.
Trial summary
ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
- Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
- At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet
Who cannot join
- Inability to operate a blood pressure 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 (frequent "no shows")
- 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)
- Primary care provider rules out the patient due to comorbidities or other factors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94123
About this study
Official title: Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.
Read the detailed description
The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).
Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).
- 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 will provide the treating physician with a treatment action recommendation for consideration.
| Study group | Role | What they receive |
|---|---|---|
| optima4BP | Experimental | optima4BP will receive several types of data to personalize the participant's medication treatment. The data include: remotely measured blood pressure (BP), and information on current medication treatment as well as health updates posted in Epic Electronic Record. Receives: Other: optima4BP |
| Standard of Care | No intervention | The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in systolic BP [SBP] (mmHg) measure in the office
optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care
Measured: 12 months
Secondary outcomes (2)
Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care baseline through 12 months of enrollment.
Measured: 12 months
Incidence of Adverse Events
Frequency and severity of adverse events (AEs) between baseline and the end of the study.
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 posted12 Jan 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: This study was dependent on an IT interoperability component requiring additional development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- The interventional arm outcomes will be compared to the control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optima Integrated Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Gabriela Voskerician, Principal investigator, Optima Integrated Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397524
- Sponsor's protocol ID
- 17-21426
- Acronym
- ARTERY
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
- ClinicalTrials.gov ID
- NCT03397524
- Acronym / sponsor ID
- ARTERY / 17-21426
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was dependent on an IT interoperability component requiring additional development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Optima Integrated HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.
Detailed description
The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).
Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The interventional arm outcomes will be compared to the control.
| Arm | Type | Receives |
|---|---|---|
| optima4BP | Experimental | Other: optima4BPoptima4BP will receive several types of data to personalize the participant's medication treatment. The data include: remotely measured blood pressure (BP), and information on current medication treatment as well as health updates posted in Epic Electronic Record. |
| Standard of Care | No intervention | –The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two or more blood pressure readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
- Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
- At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet
Key exclusion criteria (8 listed)
- Inability to operate a blood pressure 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 (frequent "no shows")
- Planned coronary revascularization in the next 12 months
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 will provide the treating physician with a treatment action recommendation for consideration. | Other | optima4BP |
Primary outcome
Reduction in systolic BP [SBP] (mmHg) measure in the office
Time frame: 12 months
optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care
2 secondary outcomes
Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
Time frame: 12 months
Incidence of Adverse Events
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No. The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
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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 principal investigator
Optima Integrated Health
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Sep 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in systolic BP [SBP] (mmHg) measure in the office (time frame: 12 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 Sep 2019.