{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiovascular Sciences, University of Birmingham, Birmingham, England, UK",
        "NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Matthew Chapman"
    },
    {
      "affiliations": [
        "Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "Jonathan E Knikman"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Sciences, University of Birmingham, Birmingham, England, UK",
        "NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Alastair Mobley"
    },
    {
      "affiliations": [
        "Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "Bart Lagerwaard"
    },
    {
      "affiliations": [
        "Internal Medicine Department, Hypertension Unit, Clinical Hospital of Valencia, Valencia, Spain",
        "Cardiometabolic Research Group, Research Institute of the Clinical Hospital of Valencia (INCLIVA), Valencia, Spain",
        "University of Valencia, Valencia, Spain"
      ],
      "name": "Fernando Martinez-Garcia"
    },
    {
      "affiliations": [
        "London School of Economics and Political Science, London, UK"
      ],
      "name": "Seraphine Zeitouny"
    },
    {
      "affiliations": [
        "Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"
      ],
      "name": "Daniel Engler"
    },
    {
      "affiliations": [
        "Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"
      ],
      "name": "Renate B Schnabel"
    },
    {
      "affiliations": [
        "Department of Vascular Medicine, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands"
      ],
      "name": "Wilko Spiering"
    },
    {
      "affiliations": [
        "Department of Vascular Medicine, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands"
      ],
      "name": "Iris D Bos"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Sciences, University of Birmingham, Birmingham, England, UK",
        "NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "A Champsi"
    },
    {
      "affiliations": [
        "London School of Economics and Political Science, London, UK"
      ],
      "name": "Alexander W Carter"
    },
    {
      "affiliations": [
        "Metabolomics and Analytics Centre, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands"
      ],
      "name": "Thomas Hankemeier"
    },
    {
      "affiliations": [
        "Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "Diederick Grobbee"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Sciences, University of Birmingham, Birmingham, England, UK",
        "NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK",
        "Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "Dipak Kotecha"
    },
    {
      "affiliations": [],
      "name": "HYPERMARKER Consortium"
    }
  ],
  "title": "Personalised approach to hypertension treatment: protocol for the HYPERMARKER randomised controlled trial",
  "uid": "fcc9540e-a829-50dc-9487-a72c5a2c46bd"
}