Personalised Continuous Dose Titration of Combination Therapy for Hypertension Using CURATE: AI Personalised Continuous Dose Titration Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration.
研究概览
简要总结
Hypertension - a chronic condition of elevated blood pressure (BP) - is a highly prevalent condition. However, effective prevention and management of hypertension remain challenging under the current standard of care (SOC). There has been a growing recognition that one-off, irregular office BP measurements are not sufficient and that regular home BP monitoring will likely be an adjunct to conventional office BP measurements. By using artificial intelligence (AI), via the CURATE.AI platform, the goal is to use patients' BP data to rapidly generate personalized anti-hypertensive dose titrations. The main aim of this study is to assess the feasibility of CURATE.AI-assisted dose titration.
详细描述
The primary aim is to assess the feasibility of CURATE.AI-assisted dose titration intervention (daily home BP monitoring via telemonitoring BotMD Care platform combined with personalized continuous dose titration based on CURATE.AI recommendations to treating physicians).
The secondary objective is to evaluate the safety and generate estimates of effect size using a small three-arm study design (N=45; 1:1:1 randomization), to inform the power analysis and sample size calculation for a larger randomized controlled trial (RCT) evaluating the efficacy and safety of the CURATE.AI-assisted dose titration intervention. The other aim is to also understand the potential efficacy of the CURATE.AI-assisted dose titration intervention to improve treatment efficacy outcomes.
The investigators hypothesize that it will be logistically and scientifically feasible to use CURATE.AI-assisted dose titration for the management of hypertension,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least >=30 years of age and <=80 years
- •History of uncontrolled primary hypertension, BPs more >=140/90mm Hg, treatment-naive or on single antihypertensive medication
- •Not known to have complications of hypertension
- •Sufficiently fluent in English language
- •Able to give informed consent
- •eGFR > 60 ml/min
- •Eligible to undergo CCB + ARB/ACE-i therapy for =30 days
排除标准
- •Suspected or known secondary hypertension
- •Drug allergies to anti-hypertensive agents or agents of the same drug class used in the protocol
- •Known postural hypotension or standing systolic blood pressure < 110 mmHg
- •Malignant hypertension (BPs = 180/110 mmHg) that requires emergency treatment
- •Arm circumference that does not fit BP cuff size which can affect the accuracy of BP measurement
- •Pregnant women, trying to become pregnant or of child-bearing potential and not using birth control
- •History of cancer
- •Chronic kidney disease (eGFR <50ml/min) or end stage renal failure
- •Liver cirrhosis or hepatic failure
- •Chronic heart failure
- •Chronic lung disease
- •Diabetes Mellitus on insulin and/or with microvascular/macrovascular complications.
- •Established cardiovascular disease such as stroke/transient ischemic attack and ischemic heart disease
- •Potential psychosocial factors or serious medical conditions limiting the ability to self-monitor their blood pressure or limit adherence to interventions (E.g. dementia, active substance abuse, nursing home resident)
- •Participants without informed consent
结局指标
主要结局
Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration.
时间窗: 30 days
A composite of the percentages will be use to obtain overall logistical feasibility of the protocol * BP monitoring adherence: Percentage of BP entries by participants into telehealth platform * Drug dose adherence percentage * Physician acceptability of CURATE.AI dose recommendations: the percentage of CURATE.AI recommended doses that were prescribed by the treating physician(s)
Scientific Feasibility
时间窗: 30 days
A composite of the percentages will be use to obtain overall scientificl feasibility of the protocol * CURATE.AI applicability: percentage of participants in whom CURATE.AI profiles can be generated and applied * Percentage of dosing cycles, out of 10 dosing cycles, that CURATE.AI recommends dose with calibration and efficacy intent to physicians * Percentage of participants with clinically significant dose changes: the cumulative dose is substantially (≥10%) different from the projected standard of care cumulative dose
次要结局
- Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol.(3 months)
- Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.(3 months)
研究者
Laureen Yi-Ting Wang
Principal investigator
Alexandra Hospital