Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Birmingham

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

400 Participants
are divided into 2 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