OUTREACH: Urine Analysis and Antihypertensive Treatment (OUTREACH)

January 8, 2024 updated by: Maciej Tomaszewski, University of Manchester

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE24 0GE
        • Alvaston Medical Centre
      • Epsom, United Kingdom, KT17 1HB
        • Epsom & St. Helier University Hospitals NHS Trust
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield General Hospital
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' Hospital
      • London, United Kingdom
        • Homerton Hospital
      • London, United Kingdom
        • St Bartholomews Hospital
      • Nottingham, United Kingdom, NG9 6DX
        • Chilwell Valley and Meadows Practice
      • Poole, United Kingdom, BH15 2JB
        • University Hospitals Dorset NHS Foundation Trust
    • Greater London
      • London, Greater London, United Kingdom
        • University College London Hospitals NHS Foundation Trust
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
    • Scotland
      • Dundee, Scotland, United Kingdom, DD2 1SY
        • Ninewells Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

    (i) Including admission to A&E

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention.
Other: 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
Active Comparator: Arm B
Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.
Other: Standard care
Standard care for hypertensive patients
Active Comparator: Arm C
Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care.
Other: Standard care
Standard care for hypertensive patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in clinic systolic blood pressure
Time Frame: visit 5 (long term follow-up; ~4.5 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
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)
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
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)
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
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)
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).
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)
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).
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)
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
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)
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.
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)
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.
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)
Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
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)
Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
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)
Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
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)
Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in psychological profile
Time Frame: visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5
visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)
Changes in psychological profile
Time Frame: visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)
Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5
visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Heart Foundation
Manchester Academic Health Science Centre
Omron Healthcare Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maciej Tomaszewski, Prof., MD, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R120993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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