AI for Anti-hypertensive Medication Titration

Study Overview
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Brief Summary
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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.

Detailed Description
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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,

Official Title
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Personalised Continuous Dose Titration of Combination Therapy for Hypertension Using CURATE: AI Personalised Continuous Dose Titration Platform

Conditions
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Hypertension, Cardiovascular Diseases

Intervention / Treatment
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* Device: Curate.AI
* Behavioral: Telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This is a 3 armed study. Control = SOC, 15 participants CURATE.AI (device)+telemonitoring= 15 participants. Telemonitoring without CURATE.AI= 15 participants. The rationale for the 3rd arm is that the process of telemonitoring itself can result in behavior change and affect blood pressure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Telemonitoring group<br> | Behavioral: Telemonitoring<br>* Patients will report their blood pressure to a telemonitoring health platform<br>|
| Active Comparator: AI. + Telemonitoring group<br> | Device: Curate.AI<br>* Personalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI<br>Behavioral: Telemonitoring<br>* Patients will report their blood pressure to a telemonitoring health platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration. | 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) | 30 days | 
| Scientific Feasibility | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. | Mean change and time taken for in office BP between baseline and 1-month clinic visit towards reaching the target office systolic BP<140mmHg and diastolic BP<90mmHg. | 3 months | 
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. | -Percentage of participants with office systolic BP<140mmHg and/OR diastolic BP<90mmHg at 1-month. | 3 months | 
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. | -Time in therapeutic range: the percentage of home BP measurements recorded within the target home range during the CURATE.AI-assisted efficacy-driven dose recommendation stage | 3 months | 
| Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol. | The composite of hospitalizations due to hypotension, bradycardia, hyperkalemia, or acute kidney injury. | 3 months |