Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change in home Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
Trial design and setting:
HYPERMARKER is a proof-of-concept, pragmatic, adaptive, open-label strategy trial embedded in routine clinical practice with stratified individual patient randomisation. The setting is secondary care, including four hospital sites in four countries (Germany, the Netherlands, Spain and the United Kingdom). Potential participants can be identified at sites from referrals, hospital clinics, ambulatory care centres, during hospital admissions by their care team or members of the research team contracted at the site. Eligibility should be confirmed by medically-qualified personnel. Except for the enrolment process and optional final blood test, the trial can be managed remotely, or with in-person visits as preferred by sites and participants.
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). The trial is organised into two phases to iterate and improve the pharmacometabolomic approach, and ensure that all patients included in the trial have access to the intervention. 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.
The range of drugs considered by the pharmacometabolomic approach are well-established hypertension medications that are the core basis of usual standard of care for hypertension treatment. All prescription decisions are made by the local Investigator who should be clinically-qualified with a license to practice and prescribe.
Enrolment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in home Systolic Blood Pressure
时间窗: 5 weeks
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).
次要结局
- 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 withdrawal of an anti-hypertensive medication.(4 weeks)
- Proportion of participants reporting ≥90% adherence to prescribed anti-hypertensive medication(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)
- Rate of change in home SBP using all available SBP measurements, averaged per week.(5 weeks)
- Change in home diastolic blood pressure derived from all available blood pressure recordings.(5 weeks)
- Change in home SBP using all available SBP measurements.(9 weeks)
- Patient-reported treatment-related side effects(8 weeks)
- Proportion and number of serious adverse events, including all-cause hospitalisation and death(9 weeks)
- Proportion and number of healthcare utilisation events, including details on hospitalisation (frequency, cause, type [outpatient, emergency, admission] and length of stay) and primary care interaction (frequency, cause and type [doctor, nurse, other(9 weeks)
- Patient-reported quality of life using the EQ-5D-5L summary index score and visual analogue scale.(9 weeks)