Trial Outcomes & Findings for Tailored Drug Titration Using Artificial Intelligence (NCT NCT04223934)
NCT ID: NCT04223934
Last Updated: 2026-07-20
Results Overview
SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care \[Time frame: 0 - 6 months\].
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-20
Participant Flow
Participant milestones
| Measure |
optima4BP
Treating physicians receive periodic (every 5-8 weeks) medication treatment recommendations intended to optimize the current patient treatment. Physicians were not enrolled/randomized to the study arms.
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.
optima4BP: 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.
|
Standard of Care (SOC)
The treating physician follows usual care practices. Physicians were not enrolled/randomized to the study arms.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
81
|
|
Overall Study
COMPLETED
|
84
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tailored Drug Titration Using Artificial Intelligence
Baseline characteristics by cohort
| Measure |
optima4BP
n=84 Participants
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=81 Participants
The treating physician follows usual care practices.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.7 • n=20 Participants
|
64.4 years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
64.95 years
STANDARD_DEVIATION 0.78 • n=40 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
87 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=20 Participants
|
72 Participants
n=20 Participants
|
145 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Systolic Blood Pressure (SBP)
|
155.8 mmHg
STANDARD_DEVIATION 11.8 • n=20 Participants
|
157 mmHg
STANDARD_DEVIATION 15.5 • n=20 Participants
|
156 mmHg
STANDARD_DEVIATION 14 • n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Enrolled participants were 21 - 80 years, with hypertension (HTN), SBP \>= to 145 mmHg, taking at least one HTN agent. Participants were cared for by PCPs at UCSF, had to be able to operate a BP cuff, access the internet and operate a smartphone, be compliant with clinic appointments, and had to not have recent CVD events or planned CVD procedures in the following year. Eligible participants were enrolled in the trial if the baseline home SBP was greater than 140 mmHg at the enrollment visit.
SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care \[Time frame: 0 - 6 months\].
Outcome measures
| Measure |
optima4BP
n=84 Participants
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=81 Participants
The treating physician follows usual care practices.
|
|---|---|---|
|
Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months]
SBP change at month 6 (mmHg)
|
17.5 mmHg
Standard Deviation 5
|
15.1 mmHg
Standard Deviation 3.5
|
|
Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months]
DBP change at month 6 (mmHg)
|
7.8 mmHg
Standard Deviation 0.7
|
5.8 mmHg
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants in the ARTERY Outcomes clinical trial.
Incidence of adverse events (AEs) during the course of the study \[12 months\].
Outcome measures
| Measure |
optima4BP
n=81 Participants
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=84 Participants
The treating physician follows usual care practices.
|
|---|---|---|
|
Incidence of Adverse Events [Time Frame: Full 12 Months]
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsWithout o4BP intervention, the o4BP arm will maintain a remote systolic blood pressure (SBP) reduction compared to the SOC arm.
Outcome measures
| Measure |
optima4BP
n=84 Participants
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=81 Participants
The treating physician follows usual care practices.
|
|---|---|---|
|
SBP at12 Months (End of Study)]
SBP at 12 months (mmHg)
|
135.9 mmHg
Standard Deviation 15.2
|
141.6 mmHg
Standard Deviation 17.2
|
|
SBP at12 Months (End of Study)]
DBP at 12 months (mmHg)
|
80.4 mmHg
Standard Deviation 10.6
|
85.5 mmHg
Standard Deviation 12.3
|
|
SBP at12 Months (End of Study)]
SBP at Baseline
|
155.8 mmHg
Standard Deviation 11.8
|
157.0 mmHg
Standard Deviation 15.5
|
|
SBP at12 Months (End of Study)]
DBP at Baseline
|
90.6 mmHg
Standard Deviation 10.0
|
91.6 mmHg
Standard Deviation 11.5
|
Adverse Events
optima4BP
Serious events: 4 serious events
Other events: 1 other events
Deaths: 5 deaths
Standard of Care (SOC)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
optima4BP
n=84 participants at risk
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=81 participants at risk
The treating physician follows usual care practices.
|
|---|---|---|
|
Nervous system disorders
Stroke/TRANSIENT ISCHEMIC ATTACK
|
1.2%
1/84 • Number of events 2 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
1.2%
1/81 • Number of events 1 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
|
Cardiac disorders
Heart Failure
|
1.2%
1/84 • Number of events 1 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
1.2%
1/81 • Number of events 1 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
|
Cardiac disorders
Hypertensive Emergency
|
2.4%
2/84 • Number of events 2 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
3.7%
3/81 • Number of events 3 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
Other adverse events
| Measure |
optima4BP
n=84 participants at risk
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.
optima4BP: 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.
|
Standard of Care (SOC)
n=81 participants at risk
The treating physician follows usual care practices.
|
|---|---|---|
|
Cardiac disorders
Syncope
|
1.2%
1/84 • Number of events 1 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
0.00%
0/81 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/84 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
1.2%
1/81 • Number of events 1 • 12 months
Adverse events were surveyed by querring the patients at pre-specified intervals. All-Cause Mortality was monitored/assessed.
|
Additional Information
Dr. Liviu Klein, MD, MS
University of California San Francisco
Phone: 4155024243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place