Clinical trial NCT05376683: AI for Anti-hypertensive Medication Titration
Official title: Personalised Continuous Dose Titration of Combination Therapy for Hypertension Using CURATE: AI Personalised Continuous Dose Titration Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Lead sponsor: Alexandra Hospital
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
First posted: 2022-05-17
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: OTHER

Brief summary: 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: 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,

Eligibility criteria: 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

Primary outcomes:
measure: Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration.
timeFrame: 30 days
measure: Scientific Feasibility
timeFrame: 30 days
Secondary outcomes:
measure: Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
timeFrame: 3 months
measure: Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
timeFrame: 3 months
measure: Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
timeFrame: 3 months
measure: Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol.
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
Study officials:
References:
citation: Blasiak A, Khong J, Kee T. CURATE.AI: Optimizing Personalized Medicine with Artificial Intelligence. SLAS Technol. 2020 Apr;25(2):95-105. doi: 10.1177/2472630319890316. Epub 2019 Nov 26.