Hypertension
Conditions
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.
Interventions
OTHERoptima4BP
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.
Sponsors
Optima Integrated Health
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient blinded to assignment \[intervention versus control\].
Intervention model description
Randomized, intervention versus control.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months] | 6 months | SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care \[Time frame: 0 - 6 months\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events [Time Frame: Full 12 Months] | 12 months | Incidence of adverse events (AEs) during the course of the study \[12 months\]. |
| SBP at12 Months (End of Study)] | 12 months | Without o4BP intervention, the o4BP arm will maintain a remote systolic blood pressure (SBP) reduction compared to the SOC arm. |
Countries
United States
Contacts
STUDY_DIRECTORGabriela Voskerician, PhD
Optima Integrated Health
PRINCIPAL_INVESTIGATORLiviu Klein, MD
University of California, San Francisco
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 86 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 44 Participants |
| Systolic Blood Pressure (SBP) | 157 mmHg STANDARD_DEVIATION 15.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 84 | 5 / 81 |
| other Total, other adverse events | 1 / 84 | 1 / 81 |
| serious Total, serious adverse events | 4 / 84 | 5 / 81 |
Outcome results
None listed