[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615606":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":99,"collaborators":101,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":25,"enrollmentInfo":125,"targetDuration":25,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":140,"whyStopped":25,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","Up front prescription based on the usual standard of care, followed by the latest iteration of the pharmacometabolomic approach",[13,14],"Other: Standard of Care (SOC)","Other: Pharmacometabolomic approach",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B","EXPERIMENTAL","Up-front initial pharmacometabolomic approach, followed by an iterated version of the pharmacometabolomic approach",[14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Standard of Care (SOC)","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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Pharmacometabolomic approach","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.",[9,16],[31,50,66,82],{"facility":32,"status":25,"city":33,"state":25,"zip":25,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"University Medical Center Hamburg-Eppendorf","Hamburg","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],9.99302,53.55073,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Renate Schnabel","CONTACT","+49 40 7410-53979","r.schnabel@uke.de",{"name":44,"role":49,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":51,"status":25,"city":52,"state":25,"zip":25,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University Medical Centre Utrecht","Utrecht","Netherlands","NL",{"type":37,"coordinates":56},[57,58],5.12222,52.09083,{"lat":58,"lon":57},[61,65],{"name":62,"role":45,"phone":63,"phoneExt":25,"email":64},"Dr Wilko Spiering","+31 8875711 88","w.spiering@umcutrecht.nl",{"name":62,"role":49,"phone":25,"phoneExt":25,"email":25},{"facility":67,"status":25,"city":68,"state":25,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"INCLIVA, Biomedical Research Institute","Valencia","Spain","ES",{"type":37,"coordinates":72},[73,74],-0.37966,39.47391,{"lat":74,"lon":73},[77,81],{"name":78,"role":45,"phone":79,"phoneExt":25,"email":80},"Fernando Martinez-Garcia","+34 679663209","fermar23@uv.es",{"name":78,"role":49,"phone":25,"phoneExt":25,"email":25},{"facility":83,"status":25,"city":84,"state":85,"zip":25,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University Hospitals Birmingham, NHS Foundation Trust","Birmingham","West Midlands","United Kingdom","UK",{"type":37,"coordinates":89},[90,91],-1.89983,52.48142,{"lat":91,"lon":90},[94,98],{"name":95,"role":45,"phone":96,"phoneExt":25,"email":97},"Matthew Chapman","+44 1213718145","matthew.chapman@uhb.nhs.uk",{"name":95,"role":49,"phone":25,"phoneExt":25,"email":25},{"type":100,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[102,104,106,108,110,112],{"name":103,"class":6},"University Hospital Birmingham NHS Foundation Trust",{"name":105,"class":6},"Instituto de Investigacion Sanitaria INCLIVA",{"name":107,"class":6},"Universitätsklinikum Hamburg-Eppendorf",{"name":109,"class":6},"London School of Economics and Political Science",{"name":111,"class":6},"Leiden University",{"name":113,"class":114},"Julius Centre for Health Sciences and Primary Care, UMC Utrecht","UNKNOWN","100615606","personalised-pharmacometabolomic-guided-strategy-trial-to-optimise-treatment-for-hypertension-100615606",false,"NCT07294794","Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension","Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER)","HYPERMARKER","Inclusion Criteria:\n\n1. Systolic blood pressure ≥140 mmHg on any blood pressure recording method (office, home or ambulatory)\n2. Age 18 years or older\n3. Clinical indication for antihypertensive therapy\n\nExclusion Criteria:\n\n1. Systolic blood pressure ≥180 mmHg on any blood pressure recording method (office, home or ambulatory)\n2. Potential secondary cause of hypertension, including but not limited to renovascular hypertension, endocrine conditions, chronic kidney disease, coarctation of the aorta or medication related.\n3. Three or more current anti-hypertensive medications\n4. Planned intervention for hypertension, such as renal denervation\n5. Severe kidney disease (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin)\n6. Diagnosis of known heart failure with left ventricular ejection fraction \\\u003C40%\n7. Stroke or myocardial infarction within the last 6 months\n8. Pregnancy, planning for pregnancy, or breastfeeding\n9. Participant whom the Clinical Investigator deems otherwise ineligible","ALL","18 Years",{"count":126,"type":127},400,"ESTIMATED","INTERVENTIONAL",[130],"NA","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.\n\nHYPERMARKER 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\n\nDeveloped 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.\n\nThe study's main outcome is home BP readings. Participants will also complete web-based questionnaires about their health, diet, treatment experience, and healthcare usage.\n\nParticipants 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.\n\nOnly medications licensed for hypertension will be used. All prescriptions are determined by clinicians throughout the trial.\n\nThe 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.",[133],"Hypertension",[135,136,137,138,139],"metabolomics","pharmacometabolomics","personalised management","blood pressure","machine learning","NOT_YET_RECRUITING","2025-12-08",{"date":143,"type":144},"2025-12-19","ACTUAL",{"date":146,"type":127},"2026-01-19",{"date":148,"type":127},"2026-12-31",{"name":5,"class":6},4]