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Personalised approach to hypertension treatment: protocol for the HYPERMARKER randomised controlled trial
Matthew Chapman1,2, Jonathan E Knikman3, Alastair Mobley1,2
1Department of Cardiovascular Sciences, University of Birmingham, Birmingham, England, UK.
This study investigates personalized hypertension treatment using a digital tool combining patient data and metabolomics. The goal is to improve blood pressure management and reduce health burdens.
Area of Science:
- Cardiovascular Medicine
- Digital Health
- Metabolomics
Background:
- Individual blood pressure treatment response varies significantly, often relying on clinician experience.
- Personalized medicine approaches, including patient empowerment and metabolomic profiles augmented by machine learning, show promise but lack robust evaluation.
- The HYPERMARKER trial aims to address the global health and economic burdens of hypertension by evaluating an individualized medication class selection.
Purpose of the Study:
- To evaluate the effectiveness of a digital portal for shared decision-making in hypertension therapy selection.
- To assess the impact of combining clinical features and metabolomic profiles for personalized antihypertensive medication class choice.
- To determine if an individualized approach enhances clinical effectiveness in managing hypertension.
Main Methods:
- A pragmatic, multicentre, adaptive, open-label strategy trial with stratified randomization.
- An intervention utilizing a digital portal for shared decision-making, incorporating clinical features and metabolomic profiles (liquid chromatography-mass spectrometry).
- 400 participants randomized to standard care or the intervention group, with remote follow-up via smartphone app and linked blood pressure monitor to assess home systolic blood pressure changes over 4 weeks.
Main Results:
- Primary outcome: Change in home systolic blood pressure during a 4-week period after medication changes.
- Secondary outcomes: Patient-reported adverse effects, quality of life, treatment withdrawal, healthcare utilization, and health economic analysis.
- Trial design includes a second phase where all participants receive the updated intervention.
Conclusions:
- The HYPERMARKER trial will provide crucial data on the clinical effectiveness of a novel, personalized approach to hypertension management.
- Findings are expected to inform future strategies for optimizing antihypertensive therapy and reducing the global burden of hypertension.
- The study emphasizes patient empowerment and the integration of advanced diagnostics (metabolomics) in routine clinical practice.
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