AI for Anti-hypertensive Medication Titration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-04-20

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.

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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,

Conditions

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Hypertension Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a 3 armed study.

1. Control = SOC, 15 participants
2. CURATE.AI (device)+telemonitoring= 15 participants.
3. 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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Telemonitoring group

Group Type ACTIVE_COMPARATOR

Telemonitoring

Intervention Type BEHAVIORAL

Patients will report their blood pressure to a telemonitoring health platform

AI. + Telemonitoring group

Group Type ACTIVE_COMPARATOR

Curate.AI

Intervention Type DEVICE

Personalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI

Telemonitoring

Intervention Type BEHAVIORAL

Patients will report their blood pressure to a telemonitoring health platform

Interventions

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Curate.AI

Personalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI

Intervention Type DEVICE

Telemonitoring

Patients will report their blood pressure to a telemonitoring health platform

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No