OUTREACH: Urine Analysis and Antihypertensive Treatment
NCT ID: NCT03293147
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2018-12-18
2023-09-30
Brief Summary
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Detailed Description
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An ultra-sensitive and highly specific biochemical assay has been developed to detect urinary biomarkers of antihypertensive treatment. The high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40 commonly prescribed blood pressure lowering medications. The results of the test provide a clinician with information on the presence/absence of prescribed antihypertensive drugs or/and their metabolites in urine - a direct confirmation of therapeutic adherence/non-adherence.
The study is a prospective multi-centre randomised controlled trial to examine if HPLC-MS/MS-guided intervention is superior to standard clinical care in improving clinical, behavioural and health-economy outcomes in hypertensive patients who are non-adherent to antihypertensive treatment.
Patient adherence to antihypertensive treatment will be determined at baseline. Non-adherent hypertensive patients at baseline will be randomised in a 1:1 ration to either usual clinical care plus HPLC-MS/MS-guided intervention (Arm A) or usual clinical care only (Arm B).
The study also evaluates a cohort of patients who are adherent to antihypertensive treatment at baseline. Those adherent hypertensive patients will receive the usual clinical care (Arm C). The main purpose of involving this group of patients is to blind the clinical research staff to the adherence status of those patients randomised receiving standard care alone, to prevent introducing any bias in treating non-adherent patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Non-adherent patients allocated to Arm A will be un-blinded at the stage of visit 3 where the results of their HPLC-MS/MS urine test will be revealed to them as a part of HPLC-MS/MS-guided intervention. The doctor will also require un-blinding to provide the required intervention. However, during further study visits the research personnel will remain blinded as to the adherence status of these patients, the results of their HPLC-MS/MS-based analysis and the treatment allocation. The doctor who delivers the intervention will not be involved in collecting clinical information necessary to define outcomes during appointments 4 and 5.
Hypertensive patients randomised to Arms B and C will remain blinded to the results of their HPLC-MS/MS-based urine test throughout all stages of the study.
Study Groups
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Arm A
Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention.
HPLC-MS/MS-guided intervention
The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment
Arm B
Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.
Standard care
Standard care for hypertensive patients
Arm C
Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care.
Standard care
Standard care for hypertensive patients
Interventions
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HPLC-MS/MS-guided intervention
The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment
Standard care
Standard care for hypertensive patients
Eligibility Criteria
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Inclusion Criteria
* Patients previously diagnosed with and pharmacologically managed for hypertension
* Patients with antihypertensive treatment with at least two antihypertensive medications
* Patients have full capability of providing informed consent
Exclusion Criteria
* Patient refusal for 7-day home-based blood pressure monitoring (7-HBBPM)
* Self-reported pregnancy or breastfeeding
* Female patients planning to conceive within the next 6 months
(i) Including admission to A\&E
18 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
Manchester Academic Health Science Centre
OTHER
Omron Healthcare Co., Ltd.
INDUSTRY
University of Manchester
OTHER
Responsible Party
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Maciej Tomaszewski
Professor of Cardiovascular Medicine
Principal Investigators
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Maciej Tomaszewski, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Alvaston Medical Centre
Derby, , United Kingdom
Epsom & St. Helier University Hospitals NHS Trust
Epsom, , United Kingdom
Glenfield General Hospital
Leicester, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
Homerton Hospital
London, , United Kingdom
St Bartholomews Hospital
London, , United Kingdom
Chilwell Valley and Meadows Practice
Nottingham, , United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, , United Kingdom
Countries
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Other Identifiers
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R120993
Identifier Type: -
Identifier Source: org_study_id
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