Hypertension Circulatory System
Conditions
Interventions
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
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Systolic blood pressure =140 mmHg on any blood pressure recording method (office, home or ambulatory) 2. Age 18 years or older 3. Clinical indication for antihypertensive therapy
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure =180 mmHg on any blood pressure recording method (office, home or ambulatory) 2. Potential secondary cause of hypertension, including but not limited to renovascular hypertension, endocrine conditions, chronic kidney disease, coarctation of the aorta or medication related. 3. Three or more current anti-hypertensive medications 4. Planned intervention for hypertension, such as renal denervation 5. Severe kidney disease (estimated glomerular filtration rate <30 mL/min) 6. Diagnosis of known heart failure with left ventricular ejection fraction <40% 7. Stroke or myocardial infarction within the last 6 months 8. Pregnancy, planning for pregnancy, or breastfeeding 9. Participant whom the Clinical Investigator deems otherwise ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in home systolic blood pressure (SBP) will be derived from all available patient-measured SBP recordings, 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will compare the pharmacometabolomic-guided drug class approach and standard of care groups at the end of the first phase of the trial: 1. Proportion of participants achieving a target home systolic blood pressure (SBP) of 120–129 mmHg using the average of the final 3 days of at-home blood pressure measurements from week 4 post intervention. 2. Proportion of participants reporting any treatment-related adverse effects compiled from the Summary of Product Characteristics from the different classes of anti-hypertensive medications. Adverse effects are measured using the patient reported adherence questionnaire sent at week 4 post intervention. 3. Proportion of participants reporting withdrawal of an anti-hypertensive medication. Withdrawal is measured using the patient reported adherence questionnaire sent at week 4 post intervention with a recall timeframe of two weeks. 4. Proportion of participants reporting =90% adherence to prescribed anti-hypertensive medication. Adherence is measured using the patient reported adherence questionnaire sent at week 4 post intervention with a recall timeframe of 10 days. 5. Rate of change in home SBP measured using all at-home blood pressure measurements averaged per week. 6. Change in home diastolic blood pressure derived from all available at-home blood pressure measurements. The following secondary outcomes will separately compare the original intervention, updated intervention and standard of care groups at the end of the second phase of the trial: 7. Change in home SBP using all available SBP measurements, comparing the iterated pharmacometabolomic approach versus the initial pharmacometabolomic approach, and the iterated pharmacometabolomic approach versus initial standard of care. 8. Patient-reported treatment-related side effects, comparing the iterated pharmacometabolomic approach versus the initial pharmacometabolomic approach, and the iterated pharmacometabolomic approach versus ini | — |
Countries
England, Germany, Netherlands, Spain, United Kingdom
Contacts
Public ContactAlastair Mobley
Outcome results
None listed