AI for Anti-hypertensive Medication Titration

Alexandra Hospital

Status

Enrolling

Conditions

Hypertension

Cardiovascular Diseases

Treatments

Device: Curate.AI

Behavioral: Telemonitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05376683

2022/00115

Details and patient eligibility

About

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.

Full 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,

Enrollment

45 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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