AI for Anti-hypertensive Medication Titration

May 3, 2023 updated by: Laureen Yi-Ting Wang, Alexandra Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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,

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
Time Frame: 3 months
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.
Time Frame: 3 months
-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 Frame: 3 months
-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.
Time Frame: 3 months
The composite of hospitalizations due to hypotension, bradycardia, hyperkalemia, or acute kidney injury.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandra Hospital

Collaborators

National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

February 20, 2024

Study Completion (Anticipated)

April 20, 2024

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/00115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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