About this trial
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.
Eligibility criteria
Qualifiers
Systolic blood pressure ≥140 mmHg on any blood pressure recording method (office, home or ambulatory)
Age 18 years or older
Clinical indication for antihypertensive therapy
Disqualifiers
Systolic blood pressure ≥180 mmHg on any blood pressure recording method (office, home or ambulatory)
Potential secondary cause of hypertension, including but not limited to renovascular hypertension, endocrine conditions, chronic kidney disease, coarctation of the aorta or medication related.
Three or more current anti-hypertensive medications
Planned intervention for hypertension, such as renal denervation
Trial design
Treatments tested in this trial
- Standard of Care (SOC)
- Pharmacometabolomic approach
Treatment groups
Sponsors and collaborators
University of Birmingham
Lead sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborator
Instituto de Investigacion Sanitaria INCLIVA
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
London School of Economics and Political Science
Collaborator
Leiden University
Collaborator
Julius Centre for Health Sciences and Primary Care, UMC Utrecht
Collaborator