Personalised approach to hypertension treatment: protocol for the HYPERMARKER randomised controlled trial

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Abstract
Introduction: Blood pressure treatment response is variable in individual patients, and the choice of medical therapy is often dependent on clinician experience. Treatment choices could be personalised by patient empowerment and metabolomic profiles, and augmented by machine learning, but robust evaluation is lacking on how these can be combined to enhance clinical effectiveness. The HYPERMARKER trial will evaluate how an individualised choice of medication class can address the avoidable global health and economic burdens of hypertension. Methods and analysis: The HYPERMARKER trial is a proof-of-concept, pragmatic, multicentre, adaptive, open-label strategy trial embedded into routine clinical practice with stratified individual patient randomisation. The trial was co-designed with a patient and public involvement team. The intervention is a digital portal that supports shared decision-making on hypertension therapy class using clinical features plus metabolomic profiles determined with liquid chromatography-mass spectrometry. Eligible patients are aged≥18 years with a systolic blood pressure≥140 mm Hg and a clinical indication for antihypertensive therapy. 400 participants will be randomised to the usual standard of care for treatment selection or to the intervention group. Remote follow-up will occur through a patient smartphone application and linked blood pressure monitor to assess the primary outcome of change in home systolic blood pressure during a 4-week period after medication changes. Secondary outcomes will include patient-reported adverse effects and quality of life, treatment withdrawal, healthcare utilisation and a health economic analysis. In the second phase of the trial, all participants will receive an updated version of the intervention regardless of the original randomised group. Ethics and dissemination: Ethical approval will be obtained for all sites. Approval in England: North West – Greater Manchester West Research Ethics Committee (REC) (25/NW/0296). Trial results will be disseminated via peer-reviewed publications and plain-language patient summaries. Trial registration number: NCT07294794 and ISRCTN29385951 .
Funding Information
  • British Heart Foundation Birmingham Accelerator (n/a)
  • Birmingham Biomedical Research Centre (NIHR203326)
  • MRC Health Data Research UK (HDRUK/CFC/01)
  • European Commission (101095480)
  • NHS Data for R&D Subnational Secure Data Environment programme (n/a)
  • The Cook & Wolstenholme Charitable Trust (n/a)
  • UKRI Horizon Europe Guarantee scheme (10061996)

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