ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Reduction in systolic BP [SBP] (mmHg) measured remotely [Time frame: 0 - 6 months]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patient blinded to assignment [intervention versus control].
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
optima4BP
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.
干预措施: optima4BP (Other)
Standard of Care (SOC)
The treating physician follows usual care practices.
结局指标
主要结局
Reduction in systolic BP [SBP] (mmHg) measured remotely [Time frame: 0 - 6 months]
时间窗: 6 months
optima4BP leads ≥4mmHg of SBP reduction compared to Standard of Care
Systolic Blood Pressure [SBP] (mmHg) Measured Remotely [Time Frame: 0 - 6 Months]
时间窗: 6 months
SBP outcome when optima4BP is used in managing hypertension treatment compared to Standard of Care \[Time frame: 0 - 6 months\].
次要结局
- Incidence of Adverse Events [Time Frame: full 12 months](6 months and 12 months)
- Sustained remote SBP Target during observational period [Time Frame: 6 - 12 months (end of study)](6 months)
- Incidence of Adverse Events [Time Frame: Full 12 Months](12 months)
- SBP at12 Months (End of Study)](12 months)