Uncomplicated HypertensionOptiZestNCT06372470
Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment
An observational study of Uncomplicated Hypertension, run by Closed Loop Medicine at 1 site in United Kingdom.
Trial summary
A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncomplicated Hypertension
- What is being tested?
- Zestril
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2024to 31 Oct 2024
- 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
- Adults aged 18 years and older.
- Patients diagnosed with uncomplicated essential (primary) hypertension eligible for Zestril per SmPC for hypertension management.
- Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
- Have access to and be able to use a suitable smartphone independently, running either iOS version 15 or later or Android version 10 or later.
Who cannot join
- Clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment).
- History of clinically important medical conditions that would compromise a patient's ability to participate safely (including an allergic reaction to Zestril/lisinopril or any other medicine and/or other contraindications and interactions listed in Zestril's SmPC).
- Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) as per SmPC
- Participants who are unwilling or unable to participate in remote study procedures, including home BP monitoring, remote consultations, and data submission as judged by the investigator.
- Any condition associated with poor compliance including alcoholism or drug dependence.
- Participants with cognitive impairments or language barriers that hinder their ability to understand and comply with study instructions and e-questionnaires.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation
- Conditions
- Uncomplicated Hypertension
- Being tested
- Zestril
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZestrilOther
N/A, this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Single cohort Receives: Other: Zestril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving target Home Blood Pressure
The number and percentage of patients achieving target Home Blood Pressure (Home Systolic Blood Pressure [HSBP] less than 135 and Home Diastolic Blood Pressure [HDBP] less than 85 mmHg for adults aged under 80; below 145/85 mmHg for adults aged 80 and over) at the optimal dose of Zestril at Week 12.
Measured: 12 weeks
Secondary outcomes (9)
Reduction in systolic blood pressure (SBP)
Mean change in SBP from baseline to the end of study Week 12
Measured: 12 weeks
Reduction in diastolic blood pressure (DBP)
Mean change in DBP from baseline to the end of study Week 12
Measured: 12 weeks
The time to achieve BP Control (BPC)
Median time from baseline to first achieving HBP control
Measured: 12 weeks
Patient daily adherence to prescribed medication
Participants' daily adherence to Zestril, assessed using the digital diary, with adherence success defined as adherence to prescribed medication on 80% or more days during the 12-week titration period
Measured: 12 weeks
Adherence to collecting data using the electronic BP diary
Adherence to collecting data using a digital diary will be determined by the percentage of the titration period during which patients input data into the blood pressure digital diary. Success will be defined as achieving 80% or more data input
Measured: 12 weeks
Patients' thoughts and feelings about BP/treatment
Patient's thoughts and emotions about BP/Treatment assessed using the Brief Illness Perception Questionnaire (B-IPQ)
Measured: 12 weeks
Discontinuation of Zestril due to unwanted side effects
Number and percentage of patients discontinuing Zestril due to unwanted side effects assessed at Week 12 using data collected from medical notes and withdrawal forms
Measured: 12 weeks
Number and type of spontaneously reported unwanted side effects
Number and type of spontaneously reported unwanted side effects, assessed at Week 12 using data reported during each consultation (Week 2,4,6,8,10,12)
Measured: 12 weeks
User experience and feasibility of the blood pressure digital diary
User experience and feasibility of the blood pressure digital diary assessed at Week 12 using the User Experience Questionnaire (UEQ)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Closed Loop Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmanovia
- Responsible party
- Sponsor
- Investigators
- Serge Engamba, MD, Principal investigator, Lead Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372470
- Sponsor's protocol ID
- CLM-HTN-005
- Acronym
- OptiZest
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 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
- Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment
- ClinicalTrials.gov ID
- NCT06372470
- Acronym / sponsor ID
- OptiZest / CLM-HTN-005
- Conditions
- Uncomplicated Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Closed Loop MedicineIndustry (pharma, biotech, devices)
- Collaborators
- Pharmanovia
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 18 Apr 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.
A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | – | Other: ZestrilSingle cohort |
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 (4 listed)
- Adults aged 18 years and older.
- Patients diagnosed with uncomplicated essential (primary) hypertension eligible for Zestril per SmPC for hypertension management.
- Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
- Have access to and be able to use a suitable smartphone independently, running either iOS version 15 or later or Android version 10 or later.
Key exclusion criteria (7 listed)
- Clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment).
- History of clinically important medical conditions that would compromise a patient's ability to participate safely (including an allergic reaction to Zestril/lisinopril or any other medicine and/or other contraindications and interactions listed in Zestril's SmPC).
- Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) as per SmPC
- Participants who are unwilling or unable to participate in remote study procedures, including home BP monitoring, remote consultations, and data submission as judged by the investigator.
- Any condition associated with poor compliance including alcoholism or drug dependence.
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. | Other | Study Arm |
Primary outcome
Achieving target Home Blood Pressure
Time frame: 12 weeks
The number and percentage of patients achieving target Home Blood Pressure (Home Systolic Blood Pressure [HSBP] less than 135 and Home Diastolic Blood Pressure [HDBP] less than 85 mmHg for adults aged under 80; below 145/85 mmHg for adults aged 80 and over) at the optimal dose of Zestril at Week 12.
9 secondary outcomes
Reduction in systolic blood pressure (SBP)
Time frame: 12 weeks
Reduction in diastolic blood pressure (DBP)
Time frame: 12 weeks
The time to achieve BP Control (BPC)
Time frame: 12 weeks
Patient daily adherence to prescribed medication
Time frame: 12 weeks
Adherence to collecting data using the electronic BP diary
Time frame: 12 weeks
Patients' thoughts and feelings about BP/treatment
Time frame: 12 weeks
Discontinuation of Zestril due to unwanted side effects
Time frame: 12 weeks
Number and type of spontaneously reported unwanted side effects
Time frame: 12 weeks
User experience and feasibility of the blood pressure digital diary
Time frame: 12 weeks
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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.
Serge Engamba, MD principal investigator
Lead Principal Investigator
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 Uncomplicated 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 4 inclusion and 7 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 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 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?
Achieving target Home Blood Pressure (time frame: 12 weeks). 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.