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Studies

Interventional Not yet recruiting

NCT07294794 on ClinicalTrials.gov

Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension

Official title: Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER)

  • Sponsor: University of Birmingham
  • Collaborators: University Hospital Birmingham NHS Foundation Trust, Instituto de Investigacion Sanitaria INCLIVA, University Medical Center Hamburg-Eppendorf (UKE), London School of Economics and Political Science, Leiden University, Julius Centre for Health Sciences and Primary Care, UMC Utrecht
  • Enrollment: 400 (Estimated)
  • Study start: 2026-01-19 (Estimated)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: The trial is organised into two phases. In the first phase, participants will be randomised to usual standard of care (group A) for treatment selection, or initial pharmacometabolomic approach (group B). In the second phase, participants originally randomised to group A will have their medications re-reviewed by the clinical investigator with access to the latest iteration of the pharmacometabolomic approach. Similarly, those originally randomised to group B will also potentially benefit from updates to the pharmacometabolomic approach during the course of the trial.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

High blood pressure (hypertension) affects 1 in 3 adults and can lead to serious health issues like strokes and heart attacks. Medication can lower blood pressure (BP) and reduce complications. Choosing the right medication can be challenging, potentially leading to side effects or poor control.

HYPERMARKER is testing whether providing doctors with additional information when they make a blood pressure prescription choice can improve a patient's overall blood pressure management. This includes relevant clinical information and personalised results from blood tests, brought together using computer programs (machine learning)- 'smart approach'. The blood tests check for small substances naturally produced by the body called metabolites

Developed with patient and public involvement, this proof-of-concept clinical trial will recruit 400 people across four sites in the UK, Spain, the Netherlands, and Germany. Participants must have a recent high blood pressure reading with a clinical need for medication. After providing written consent, they will provide a blood sample (to measure their metabolites) and receive a BP monitor connected to a smartphone app allowing them to measure and record their BP at home throughout the trial.

The study's main outcome is home BP readings. Participants will also complete web-based questionnaires about their health, diet, treatment experience, and healthcare usage.

Participants will be randomly assigned to two groups. Group A will receive medication based on standard clinical practice up-front, then investigators will receive output from the smart approach to refine the choice of treatment. In Group B, investigators will receive the output from the 'smart approach' initially, with further updates provided later.

Only medications licensed for hypertension will be used. All prescriptions are determined by clinicians throughout the trial.

The trial lasts 9-16 weeks. At the end, participants and their usual doctor get a copy of their BP readings and medication to guide their long-term care.

Conditions

  • Hypertension

Intervention / Treatment

  • Other: Standard of Care (SOC)
  • Other: Pharmacometabolomic approach

Primary Outcome Measures

  • Change in home Systolic Blood Pressure (5 weeks)
    Change in home SBP will be derived from all available patient-measured SBP recordings in the study smartphone application, comparing the intervention and standard of care groups at the end of the first phase of the trial. This includes 1-week of monitoring after enrolment (anticipated minimum of 12 recordings) and at least 4-weeks of monitoring after therapy change (anticipated minimum of 48 recordings).

Countries

Germany, Netherlands, Spain, United Kingdom

Locations and Investigators

  • University Medical Center Hamburg-Eppendorf, Hamburg, Germany
    • Renate Schnabel
    • Renate Schnabel (Principal Investigator)
  • University Medical Centre Utrecht, Utrecht, Netherlands
    • Dr Wilko Spiering
    • Dr Wilko Spiering (Principal Investigator)
  • INCLIVA, Biomedical Research Institute, Valencia, Spain
    • Fernando Martinez-Garcia
    • Fernando Martinez-Garcia (Principal Investigator)
  • University Hospitals Birmingham, NHS Foundation Trust, Birmingham, United Kingdom
    • Matthew Chapman
    • Matthew Chapman (Principal Investigator)