CURATE.AI-assisted dose titration for anti-hypertensive personalized therapy: study protocol for a multi-arm,...

Area of Science:

• Cardiology
• Medical Informatics
• Artificial Intelligence in Healthcare

Background:

• Hypertension management requires personalized treatment strategies.
• Artificial intelligence (AI)-driven platforms offer potential for optimizing anti-hypertensive dosing.
• CURATE.AI is a small data platform designed to assist physicians in personalized hypertension care.

Purpose of the Study:

• To assess the feasibility of a larger randomized controlled trial (RCT) for an AI-assisted hypertension care intervention.
• To evaluate the efficacy and safety of CURATE.AI-assisted anti-hypertensive dose titration.
• To gather stakeholder feedback for refining the intervention design.

Main Methods:

• A 1:1:1 randomized pilot feasibility trial involving 45 participants with primary hypertension.
• Intervention arms: control, home blood pressure monitoring (HBPM), and CURATE.AI (HBPM + AI-assisted dose titration).
• Primary endpoints focused on logistical and scientific feasibility for RCT progression; secondary endpoints assessed preliminary efficacy and safety.

Main Results:

• The study will determine the feasibility of CURATE.AI for personalized hypertension management.
• Preliminary efficacy data on blood pressure reduction will be collected.
• Safety data, including hospitalization events, will be analyzed across treatment arms.

Conclusions:

• Findings will inform refinements for a larger RCT of CURATE.AI.
• The study may indicate CURATE.AI's potential to enhance blood pressure control through personalized titration.
• Stakeholder feedback will guide future implementation strategies.