Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension

NCT07294794 | Not Yet Recruiting DMC

• 2 other identifiers: RG_24-123354889
• Study Type: interventional
• Target: 400
• Locations: 4 countries
• Sites: 4

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

Keywords

metabolomics; pharmacometabolomics; personalised management; blood pressure; machine learning

Outcome Measures

Primary Outcomes (1)

• 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).

  5 weeks

Secondary Outcomes (11)

• Proportion of participants achieving a target home SBP of 120-129mmHg using the average of the final 3 days of blood pressure measurements.

  4 weeks

• Proportion of participants reporting any treatment-related adverse effects compiled from the Summary of Product Characteristics from the different classes of anti-hypertensive medications

  4 weeks

• Proportion of participants reporting withdrawal of an anti-hypertensive medication.

  4 weeks

• Proportion of participants reporting ≥90% adherence to prescribed anti-hypertensive medication

  4 weeks

• Rate of change in home SBP using all available SBP measurements, averaged per week.

  5 weeks

Other Outcomes (5)

• Change in metabolomic profile from baseline to (optional) follow-up blood sample, stratified by class of anti-hypertensive medication (exploratory).

  9weeks

• Association between dietary intake, metabolomic profile and blood pressure response to prescribed antihypertensive treatment (exploratory).

  9 weeks

• Life years and quality-adjusted life year (QALY) gained

  9 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Up front prescription based on the usual standard of care, followed by the latest iteration of the pharmacometabolomic approach

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

Group B

EXPERIMENTAL

Up-front initial pharmacometabolomic approach, followed by an iterated version of the pharmacometabolomic approach

Other: Pharmacometabolomic approach

Interventions

Standard of Care (SOC) OTHER

Standard 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.

Group A

Pharmacometabolomic approach OTHER

The 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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe kidney disease (estimated glomerular filtration rate \<30 mL/min)
• Diagnosis of known heart failure with left ventricular ejection fraction \<40%
• Stroke or myocardial infarction within the last 6 months
• Pregnancy, planning for pregnancy, or breastfeeding
• Participant whom the Clinical Investigator deems otherwise ineligible

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria INCLIVA: collaborator
• London School of Economics and Political Science: collaborator
• Julius Centre for Health Sciences and Primary Care, UMC Utrecht: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• University Medical Center Hamburg-Eppendorf (UKE): collaborator
• Leiden University: collaborator
• University of Birmingham: lead

Study Sites (4)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

INCLIVA, Biomedical Research Institute

Valencia, Spain

Location

University Hospitals Birmingham, NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (1); NL (1); GB (1)