HypertensionNCT05376683
AI for Anti-hypertensive Medication Titration
A study testing Curate.AI and Telemonitoring in people with Hypertension and Cardiovascular Diseases, run by Alexandra Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- Curate.AI and Telemonitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Alexandra Hospital
Singapore, 159964
LW Wang, 69082222, laureen_yt_wang@nuhs.edu.sg
About this study
Official title: 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.
Read the 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,
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- Curate.AI, Telemonitoring
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curate.AIDevice
Personalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI
TelemonitoringBehavioural
Patients will report their blood pressure to a telemonitoring health platform
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Telemonitoring group | Active comparator | Not described Receives: Behavioral: Telemonitoring |
| AI. + Telemonitoring group | Active comparator | Not described Receives: Device: Curate.AI; Behavioral: Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 30 days
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Apr 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Laureen Yi-Ting Wang, Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376683
- Sponsor's protocol ID
- 2022/00115
- Status last verified
- May 2023
- First submitted
- 23 Apr 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31771394Truong 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.
PubMed 38264697
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Continuous Dose Titration of Combination Therapy for Hypertension Using CURATE: AI Personalised Continuous Dose Titration Platform
- ClinicalTrials.gov ID
- NCT05376683
- Acronym / sponsor ID
- 2022/00115
- Conditions
- Hypertension, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Telemonitoring group | Active comparator | Behavioral: Telemonitoring |
| AI. + Telemonitoring group | Active comparator | Device: Curate.AI, Behavioral: Telemonitoring |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curate.AIPersonalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI | Device | AI. + Telemonitoring group |
| TelemonitoringPatients will report their blood pressure to a telemonitoring health platform | Behavioural | AI. + Telemonitoring group, Telemonitoring group |
Primary outcome
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)
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
4 secondary outcomes
Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
Time frame: 3 months
Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
Time frame: 3 months
Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol.
Time frame: 3 months
Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 31771394Blasiak 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.
- Derived from this study: PubMed 38264697Truong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curate.AI and Telemonitoring in people with Hypertension and Cardiovascular Diseases, run by Alexandra Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.