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AI for Anti-hypertensive Medication Titration

Primary Purpose

Hypertension, Cardiovascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Curate.AI

Telemonitoring

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Telemonitoring group

AI. + Telemonitoring group

Arm Description

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

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.

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.

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

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.

Full Information

NCT ID

NCT05376683

First Posted

April 23, 2022

Last Updated

May 3, 2023

Sponsor

Alexandra Hospital

Collaborators

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT05376683

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

February 20, 2024 (Anticipated)

Study Completion Date

April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandra Hospital

Collaborators

National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Cardiovascular Diseases

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Title

Telemonitoring group

Arm Type

Active Comparator

Arm Title

AI. + Telemonitoring group

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Curate.AI

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Telemonitoring

Intervention Description

Patients will report their blood pressure to a telemonitoring health platform

Primary Outcome Measure Information:

Title

Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration.

Description

Time Frame

30 days

Title

Scientific Feasibility

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.

Description

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.

Time Frame

3 months

Title

Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.

Description

-Percentage of participants with office systolic BP<140mmHg and/OR diastolic BP<90mmHg at 1-month.

Time Frame

3 months

Title

Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.

Description

-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

Time Frame

3 months

Title

Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol.

Description

The composite of hospitalizations due to hypotension, bradycardia, hyperkalemia, or acute kidney injury.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Alexandra Hospital

City

Singapore

ZIP/Postal Code

159964

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LW Wang

Phone

69082222

laureen_yt_wang@nuhs.edu.sg

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31771394

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.

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AI for Anti-hypertensive Medication Titration

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