AI for Anti-hypertensive Medication Titration

NCT05376683 | Unknown DMC

• 1 other identifier: 2022/00115
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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)

  30 days

• 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

  30 days

Secondary Outcomes (4)

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

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (3)

Control

NO INTERVENTION

Telemonitoring group

ACTIVE COMPARATOR

Behavioral: Telemonitoring

AI. + Telemonitoring group

ACTIVE COMPARATOR

Device: Curate.AI; Behavioral: Telemonitoring

Interventions

Curate.AI DEVICE

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

AI. + Telemonitoring group

Telemonitoring BEHAVIORAL

Patients will report their blood pressure to a telemonitoring health platform

AI. + Telemonitoring group; Telemonitoring group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Alexandra Hospital

Singapore, 159964, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 31771394 BACKGROUND

• Truong ATL, Tan SB, Wang GZ, Yip AWJ, Egermark M, Yeung W, Lee VV, Chan MY, Kumar KS, Tan LWJ, Vijayakumar S, Blasiak A, Wang LYT, Ho D. CURATE.AI-assisted dose titration for anti-hypertensive personalized therapy: study protocol for a multi-arm, randomized, pilot feasibility trial using CURATE.AI (CURATE.AI ADAPT trial). Eur Heart J Digit Health. 2023 Oct 24;5(1):41-49. doi: 10.1093/ehjdh/ztad063. eCollection 2024 Jan.

  PMID: 38264697 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 17, 2022
• Study Start: April 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: April 20, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)