HypertensionOUTREACHNCT03293147
OUTREACH: Urine Analysis and Antihypertensive Treatment
A study testing HPLC-MS/MS-guided intervention in people with Hypertension and Adherence, Medication, run by University of Manchester at 12 sites in United Kingdom.
Trial summary
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Adherence, Medication
- What is being tested?
- HPLC-MS/MS-guided intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 18 Dec 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or above
- 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
Who cannot join
- Patients with recent history of admission to the hospital relating to their hypertension or treatment with anti-hypertensive medications (<2 weeks) (i)
- 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
- Including admission to A\&E
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Alvaston Medical Centre
Derby, DE24 0GE
Ninewells Hospital
Dundee, Scotland, DD2 1SY
Epsom & St. Helier University Hospitals NHS Trust
Epsom, KT17 1HB
Glenfield General Hospital
Leicester, LE3 9QP
University College London Hospitals NHS Foundation Trust
London, Greater London
Royal Free Hospital
London, NW3 2QG
Guy's and St Thomas' Hospital
London, SE1 7EH
Homerton Hospital
London
St Bartholomews Hospital
London
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL
Chilwell Valley and Meadows Practice
Nottingham, NG9 6DX
University Hospitals Dorset NHS Foundation Trust
Poole, BH15 2JB
About this study
Official title: BiOmarkers in Urine, anTihypeRtensive trEAtment and Blood Pressure Control in Hypertensive Patients
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our project will assess whether high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence) leads to an improvement in blood pressure control, adherence and a reduction in healthcare costs. Our multicentre prospective randomised controlled trial consists of 6 stages (screening, recruitment, baseline phenotype assessment, intervention, short-term and long-term outcome visits). The study will fill in an important gap in knowledge on management of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step. It will also inform the development of a cost-effective model for the management of non-adherence in chronic disorders that require long-term drug therapy.
Read the detailed description
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence.
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
- Hypertension, Adherence, Medication
- Being tested
- HPLC-MS/MS-guided intervention, Standard care
- Keywords
- Blood pressure, Antihypertensive treatment, Adherence, Biomarker, Urine, HPLC-MS/MS
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPLC-MS/MS-guided interventionOther
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 careOther
Standard care for hypertensive patients
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention. Receives: Other: HPLC-MS/MS-guided intervention |
| Arm B | Active comparator | Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care. Receives: Other: Standard care |
| Arm C | Active comparator | Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinic systolic blood pressure
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Measured: visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)
Secondary outcomes (12)
Change in clinic systolic blood pressure
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in clinic diastolic blood pressure
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Measured: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in clinic diastolic blood pressure
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in home blood pressure
This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).
Measured: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in home blood pressure
This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in biochemical adherence of patients
HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription
Measured: visit 2 (~3 weeks post recruitment, when feasible to conduct)
Change in biochemical adherence of patients
HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.
Measured: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in biochemical adherence of patients
HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in urinary albumin / creatinine ratio
Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
Measured: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in urinary albumin / creatinine ratio
Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Changes in health economy parameters
Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
Measured: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Changes in health economy parameters
Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
Measured: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start18 Dec 2018
- Primary completion4 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Manchester Academic Health Science Centre, Omron Healthcare Co., Ltd.
- Responsible party
- Principal investigator, Maciej Tomaszewski, University of Manchester
- Investigators
- Maciej Tomaszewski, Prof., MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293147
- Sponsor's protocol ID
- R120993
- Acronym
- OUTREACH
- Status last verified
- Jan 2024
- First submitted
- 21 Sep 2017
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomaszewski M, Gupta P, Chowienczyk P, Leurent B, Hames-Fathi S, Lenzi L, Faconti L, Abrams SML, George M, Buchanan H, Jordan A, Walsh S, Robinson V, Adlan A, Heagerty A, Squire I, Horne R, Jones E, McFarlane E, Collier D, Mackenzie IS, Patel P, MacDonald TM, Thompson A, Lacy P, Swift PA, Williams B. Chemical adherence testing-guided intervention versus standard of care in patients with hypertension who are non-adherent to antihypertensive treatment in the UK (OUTREACH): a multicentre, randomised controlled trial. Lancet Prim Care. 2026 May;2(5):None. doi: 10.1016/j.lanprc.2026.100154.
PubMed 42311955
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiOmarkers in Urine, anTihypeRtensive trEAtment and Blood Pressure Control in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03293147
- Acronym / sponsor ID
- OUTREACH / R120993
- Conditions
- Hypertension, Adherence, Medication
- Keywords
- Blood pressure, Antihypertensive treatment, Adherence, Biomarker, Urine, HPLC-MS/MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- British Heart Foundation, Manchester Academic Health Science Centre, Omron Healthcare Co., Ltd.
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our project will assess whether high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence) leads to an improvement in blood pressure control, adherence and a reduction in healthcare costs. Our multicentre prospective randomised controlled trial consists of 6 stages (screening, recruitment, baseline phenotype assessment, intervention, short-term and long-term outcome visits). The study will fill in an important gap in knowledge on management of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step. It will also inform the development of a cost-effective model for the management of non-adherence in chronic disorders that require long-term drug therapy.
Detailed description
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Multi-center randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: HPLC-MS/MS-guided interventionIntervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention. |
| Arm B | Active comparator | Other: Standard careControl group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care. |
| Arm C | Active comparator | Other: Standard careControl group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years or above
- 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
Key exclusion criteria (5 listed)
- Patients with recent history of admission to the hospital relating to their hypertension or treatment with anti-hypertensive medications (<2 weeks) (i)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPLC-MS/MS-guided interventionThe 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 | Other | Arm A |
| Standard careStandard care for hypertensive patients | Other | Arm B, Arm C |
Primary outcome
Change in Clinic systolic blood pressure
Time frame: visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
12 secondary outcomes
Change in clinic systolic blood pressure
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in clinic diastolic blood pressure
Time frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in clinic diastolic blood pressure
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in home blood pressure
Time frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in home blood pressure
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in biochemical adherence of patients
Time frame: visit 2 (~3 weeks post recruitment, when feasible to conduct)
Change in biochemical adherence of patients
Time frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in biochemical adherence of patients
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Change in urinary albumin / creatinine ratio
Time frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Change in urinary albumin / creatinine ratio
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Changes in health economy parameters
Time frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Changes in health economy parameters
Time frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 42311955Tomaszewski M, Gupta P, Chowienczyk P, Leurent B, Hames-Fathi S, Lenzi L, Faconti L, Abrams SML, George M, Buchanan H, Jordan A, Walsh S, Robinson V, Adlan A, Heagerty A, Squire I, Horne R, Jones E, McFarlane E, Collier D, Mackenzie IS, Patel P, MacDonald TM, Thompson A, Lacy P, Swift PA, Williams B. Chemical adherence testing-guided intervention versus standard of care in patients with hypertension who are non-adherent to antihypertensive treatment in the UK (OUTREACH): a multicentre, randomised controlled trial. Lancet Prim Care. 2026 May;2(5):None. doi: 10.1016/j.lanprc.2026.100154.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Tomaszewski, Prof., MD principal investigator
University of Manchester
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPLC-MS/MS-guided intervention in people with Hypertension and Adherence, Medication, run by University of Manchester at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinic systolic blood pressure (time frame: visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.