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.
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
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
Crossover
Standard of Care (SOC)
Other interventionStandard of care for this trial is defined according to the 2024 European Society of Cardiology Guidelines for the management of elevated blood pressure and hypertension.
Pharmacometabolomic approach
Other interventionThe intervention will combine metabolomic and clinical data using machine learning to provide additional information clinical investigators may utilise in their choice of blood pressure-lowering medication class for individual patients (pharmacometabolomic approach). To allow for an improved approach in the second phase of the trial, the pharmacometabolomic approach will be iterated and refined during the trial as additional metabolomic and clinical data are obtained.
Change in home Systolic Blood Pressure
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).
Proportion of participants achieving a target home SBP of 120-129mmHg using the average of the final 3 days of blood pressure measurements.
Comparing the intervention and standard of care groups at the end of the first phase of the trial
Proportion of participants reporting any treatment-related adverse effects compiled from the Summary of Product Characteristics from the different classes of anti-hypertensive medications
Comparing the intervention and standard of care groups at the end of the first phase of the trial
Proportion of participants reporting withdrawal of an anti-hypertensive medication.
Comparing the intervention and standard of care groups at the end of the first phase of the trial
Proportion of participants reporting ≥90% adherence to prescribed anti-hypertensive medication
Comparing the intervention and standard of care groups at the end of the first phase of the trial
Change in metabolomic profile from baseline to (optional) follow-up blood sample, stratified by class of anti-hypertensive medication (exploratory).
This outcome is unrelated to the randomised group
Association between dietary intake, metabolomic profile and blood pressure response to prescribed antihypertensive treatment (exploratory).
Outcome is unrelated to the randomised group
Life years and quality-adjusted life year (QALY) gained
Net monetary benefits of the pharmacometabolomic approach
Click on the lead sponsor to view all of their trials.
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
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