HypertensionNCT06745726
OptiZ: Real World Evidence Study
An observational study of Hypertension, run by Closed Loop Medicine at 1 site in United Kingdom.
Trial summary
Hypertension, or high blood pressure, is a major cause of preventable illness and premature death, affecting millions in the UK. Despite effective treatments, many patients struggle to achieve adequate blood pressure control. This study evaluates the effectiveness of the OptiZ. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Zestril
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2025to Oct 2026
- Phase
- Observational
- 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
Study population: Uncomplicated primary hypertension cohort in England
Who may be able to join
- Participants must be 18 years or older.
- Participants must have a diagnosis of essential hypertension.
- Participants must be eligible for Zestril prescription as part of their hypertension treatment plan, in line with the NICE stepwise approach, based on the clinical judgment of the responsible healthcare professional
- Participants need to be willing to self-monitor, must be able to use a smartphone (iOS 16+ or Android 11+). A carer aged 18+ can use the app on their behalf if needed.
- Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
Who cannot join
- Participants with the following comorbidities: heart failure, a history of acute myocardial infarction, renal complications associated with diabetes mellitus, known clinically significant renal impairment (eGFR < 60 ml/min/1.73 m2). Participants with a strongly activated renin-angiotensin- aldosterone system (such as those with renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension).
- Participants with severe cognitive impairment or severe visual impairment/blindness that would prevent effective use of the smartphone app or self-monitoring using a blood pressure monitor (applies only if no carer is available).
- Clinically significant abnormal blood results as judged by the responsible healthcare professional (including but not limited to, known abnormal serum potassium and/or blood urea nitrogen/serum creatinine renal).
- Failure to satisfy the responsible healthcare professional of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimising Hypertension Management: Real-World Effectiveness of Zestril Personalised Dosing With the OptiZ Software as a Medical Device Companion App
Hypertension, or high blood pressure, is a major cause of preventable illness and premature death, affecting millions in the UK. Despite effective treatments, many patients struggle to achieve adequate blood pressure control. This study evaluates the effectiveness of the OptiZ. OptiZ is a mobile phone application ("app") intended to be installed on a mobile device as part of a treatment for hypertension for use by patients prescribed Zestril (lisinopril). The OptiZ app helps patients record blood pressure, dose-related side effects, and medication adherence, send reports to healthcare professionals for dose adjustments, set reminders to log their medication and blood pressure readings, and access information about high blood pressure and health tips.
This is a real-world observational study involving adults diagnosed with essential hypertension who are eligible for Zestril treatment. Recruitment will occur at selected GP practices across England over six months, with participants followed for 12 months. The study aims to enrol 113 participants. Using the OptiZ app, participants will record daily blood pressure readings, track medication adherence, record dose-related side effects, and access educational content on hypertension management. Healthcare professionals will use reports generated by the app to personalise Zestril dosing.
Read more
The main objective is to evaluate the OptiZ app's impact on reducing systolic blood pressure during the dose adjustment phase. Secondary objectives include adherence to Zestril, how often patients log blood pressure readings onto the OptiZ app and other patient-reported outcomes. Participants will also complete electronic questionnaires to provide feedback on their experience using the OptiZ app and their perceptions of hypertension treatment.
This study is funded by Closed Loop Medicine Ltd and Atnahs Pharma UK Ltd. The findings aim to improve hypertension care by using digital tools to enhance adherence, optimise dosing, and potentially reduce cardiovascular risks while guiding future digital solutions for chronic conditions.
- Conditions
- Hypertension
- Being tested
- Zestril
- Keywords
- Hypertension, Zestril, lisinopril, mHealth, mobile app, self-monitoring, personalised medicine, blood pressure control, home blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZestrilDrug
N/A, this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | N/A, this is an observational study. Receives: Drug: Zestril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
The change in systolic blood pressure from baseline to the end of the titration period.
Measured: 12 months
Secondary outcomes (12)
Mean change in diastolic blood pressure
Mean change in DBP from baseline to the end of titration period
Measured: 12 months
Number and percentage of participants achieving target Home Blood Pressure at the end of their titration period
The number and percentage of participants achieving target HBP (home SBP [HSBP] less than 135 and home DBP [HDBP] less than 85 mmHg for adults aged under 80; below 145/85 mmHg for adults aged 80 and over) at the end of their titration period. with subsequent assessments at 4 months post successful titration and the end of the study (8-month follow-up).
Measured: 12 months
Median time from baseline to first achieving Home Blood Pressure control
Median time from baseline to first achieving Home Blood Pressure control
Measured: 12 months
Participants' daily adherence to Zestril
Participants' daily adherence to Zestril, assessed using the OptiZ App, with adherence success defined as adherence to prescribed medication on 80% or more days during the titration period.
Measured: 12 months
Adherence to collecting data using the OptiZ App
Adherence to collecting data using the OptiZ App will be determined by the percentage of the titration period during which participants input data into the OptiZ App. Success will be defined as achieving 80% or more data input
Measured: 12 months
Proportion of participants requiring re-entry into the titration phase at follow-up due to uncontrolled blood pressure
Proportion of participants requiring re-entry into the titration phase at follow-up due to uncontrolled blood pressure defined as home BP average of ≥135/85 mmHg for adults under 80 and ≥145/85 mmHg for those 80 and older.
Measured: 12 months
Healthcare professionals' concordance to the OptiZ treatment report recommendations
Healthcare professionals' concordance to the OptiZ treatment report recommendations assessed using self-reported data via an e-questionnaire after each consultation visit with a participant
Measured: 12 months
Participant's feedback using Brief Illness Perception Questionnaire
Participant's thoughts and emotions about treatment assessed using the Brief Illness Perception Questionnaire (B-IPQ) (consisting of 8 questions answered on a scale from 0 to 10 however each question is asked whereby a different a score of 0 or 10 is not consistently a better outcome; and a final question asking the participant to rank the 3 most important factors that they believe caused their illness) at baseline, end of titration period and 4-month follow up
Measured: 8 months
Number and percentage of participants discontinuing Zestril due to unwanted side effects
Number and percentage of participants discontinuing Zestril due to unwanted side effects (or other clinically significant reasons as determined by the responsible healthcare professionals) assessed using data collected from medical notes and withdrawal forms
Measured: 12 months
Number and type of spontaneously reported unwanted side effects
Number and type of spontaneously reported unwanted side effects, assessed using data reported during each consultation and from medical notes.
Measured: 12 months
User experience and feedback on the OptiZ treatment
User experience and feedback on the OptiZ treatment assessed using the User Experience Questionnaire (UEQ) used to measure user experience with 6 scales (Attractiveness, Efficiency, Perspicuity, Dependability, Stimulation and Novelty) (where questions are answered on a scale from 1 to 7 but a score of 1 or 7 does not necessarily result in a better outcome). This questionnaires will be administered at the end of titration period and 4-month follow up.
Measured: 8 months
User experience and feedback on the OptiZ treatment
User experience and feedback on the OptiZ treatment assessed using the UMUX-Lite questionnaire tailored to evaluate the specific components and features of the OptiZ App (consisting of 6 sections which all contain 2 questions where each question is answered using 'strongly agree', 'disagree', 'slightly agree', 'neither agree or disagree', 'slightly agree', 'agree', 'strongly agree' as well as a question for each section asking the participant why those scores were given). This questionnaires will be administered at the end of titration period and 4-month follow up.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study startMar 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Delays in sponsorship and funding necessitate a stop in the study set up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Closed Loop Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745726
- Sponsor's protocol ID
- CLM-HTN-006
- Status last verified
- Mar 2026
- First submitted
- 13 Dec 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Hypertension Management: Real-World Effectiveness of Zestril Personalised Dosing With the OptiZ Software as a Medical Device Companion App
- ClinicalTrials.gov ID
- NCT06745726
- Acronym / sponsor ID
- CLM-HTN-006
- Conditions
- Hypertension
- Keywords
- Hypertension, Zestril, lisinopril, mHealth, mobile app, self-monitoring, personalised medicine, blood pressure control
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Delays in sponsorship and funding necessitate a stop in the study set up.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Closed Loop MedicineIndustry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Dec 2024 (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.
Hypertension, or high blood pressure, is a major cause of preventable illness and premature death, affecting millions in the UK. Despite effective treatments, many patients struggle to achieve adequate blood pressure control. This study evaluates the effectiveness of the OptiZ. OptiZ is a mobile phone application ("app") intended to be installed on a mobile device as part of a treatment for hypertension for use by patients prescribed Zestril (lisinopril). The OptiZ app helps patients record blood pressure, dose-related side effects, and medication adherence, send reports to healthcare professionals for dose adjustments, set reminders to log their medication and blood pressure readings, and access information about high blood pressure and health tips.
This is a real-world observational study involving adults diagnosed with essential hypertension who are eligible for Zestril treatment. Recruitment will occur at selected GP practices across England over six months, with participants followed for 12 months. The study aims to enrol 113 participants. Using the OptiZ app, participants will record daily blood pressure readings, track medication adherence, record dose-related side effects, and access educational content on hypertension management. Healthcare professionals will use reports generated by the app to personalise Zestril dosing.
The main objective is to evaluate the OptiZ app's impact on reducing systolic blood pressure during the dose adjustment phase. Secondary objectives include adherence to Zestril, how often patients log blood pressure readings onto the OptiZ app and other patient-reported outcomes. Participants will also complete electronic questionnaires to provide feedback on their experience using the OptiZ app and their perceptions of hypertension treatment.
This study is funded by Closed Loop Medicine Ltd and Atnahs Pharma UK Ltd. The findings aim to improve hypertension care by using digital tools to enhance adherence, optimise dosing, and potentially reduce cardiovascular risks while guiding future digital solutions for chronic conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | Drug: ZestrilN/A, this is an observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Uncomplicated primary hypertension cohort in England
Key inclusion criteria (5 listed)
- Participants must be 18 years or older.
- Participants must have a diagnosis of essential hypertension.
- Participants must be eligible for Zestril prescription as part of their hypertension treatment plan, in line with the NICE stepwise approach, based on the clinical judgment of the responsible healthcare professional
- Participants need to be willing to self-monitor, must be able to use a smartphone (iOS 16+ or Android 11+). A carer aged 18+ can use the app on their behalf if needed.
- Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
Key exclusion criteria (4 listed)
- Participants with the following comorbidities: heart failure, a history of acute myocardial infarction, renal complications associated with diabetes mellitus, known clinically significant renal impairment (eGFR < 60 ml/min/1.73 m2). Participants with a strongly activated renin-angiotensin- aldosterone system (such as those with renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension).
- Participants with severe cognitive impairment or severe visual impairment/blindness that would prevent effective use of the smartphone app or self-monitoring using a blood pressure monitor (applies only if no carer is available).
- Clinically significant abnormal blood results as judged by the responsible healthcare professional (including but not limited to, known abnormal serum potassium and/or blood urea nitrogen/serum creatinine renal).
- Failure to satisfy the responsible healthcare professional of fitness to participate for any other reason.
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 |
|---|---|---|
| ZestrilN/A, this is an observational study. | Drug | Single cohort |
Primary outcome
Change in systolic blood pressure
Time frame: 12 months
The change in systolic blood pressure from baseline to the end of the titration period.
12 secondary outcomes
Mean change in diastolic blood pressure
Time frame: 12 months
Number and percentage of participants achieving target Home Blood Pressure at the end of their titration period
Time frame: 12 months
Median time from baseline to first achieving Home Blood Pressure control
Time frame: 12 months
Participants' daily adherence to Zestril
Time frame: 12 months
Adherence to collecting data using the OptiZ App
Time frame: 12 months
Proportion of participants requiring re-entry into the titration phase at follow-up due to uncontrolled blood pressure
Time frame: 12 months
Healthcare professionals' concordance to the OptiZ treatment report recommendations
Time frame: 12 months
Participant's feedback using Brief Illness Perception Questionnaire
Time frame: 8 months
Number and percentage of participants discontinuing Zestril due to unwanted side effects
Time frame: 12 months
Number and type of spontaneously reported unwanted side effects
Time frame: 12 months
User experience and feedback on the OptiZ treatment
Time frame: 8 months
User experience and feedback on the OptiZ treatment
Time frame: 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Closed Loop Medicine at 1 site 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 systolic blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.