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 (OptiZest)

March 18, 2026 updated by: Closed Loop Medicine
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 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.

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.
Observational

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.
20

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 Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Uncomplicated primary hypertension cohort in England

Description

Inclusion Criteria:

  1. Adults aged 18 years and older.
  2. Patients diagnosed with uncomplicated essential (primary) hypertension eligible for Zestril per SmPC for hypertension management.
  3. Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
  4. 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.

Exclusion Criteria:

  1. Clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment).
  2. 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).
  3. 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
  4. 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.
  5. Any condition associated with poor compliance including alcoholism or drug dependence.
  6. Participants with cognitive impairments or language barriers that hinder their ability to understand and comply with study instructions and e-questionnaires.
  7. Failure to satisfy the investigator of fitness to participate for any other reason.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Study Arm
Single cohort
Other: Zestril
N/A, this is an observational study.

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
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.
12 weeks

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
Reduction in systolic blood pressure (SBP)
Time Frame: 12 weeks
Mean change in SBP from baseline to the end of study Week 12
12 weeks
Reduction in diastolic blood pressure (DBP)
Time Frame: 12 weeks
Mean change in DBP from baseline to the end of study Week 12
12 weeks
The time to achieve BP Control (BPC)
Time Frame: 12 weeks
Median time from baseline to first achieving HBP control
12 weeks
Patient daily adherence to prescribed medication
Time Frame: 12 weeks
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
12 weeks
Adherence to collecting data using the electronic BP diary
Time Frame: 12 weeks
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
12 weeks
Patients' thoughts and feelings about BP/treatment
Time Frame: 12 weeks
Patient's thoughts and emotions about BP/Treatment assessed using the Brief Illness Perception Questionnaire (B-IPQ)
12 weeks
Discontinuation of Zestril due to unwanted side effects
Time Frame: 12 weeks
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
12 weeks
Number and type of spontaneously reported unwanted side effects
Time Frame: 12 weeks
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)
12 weeks
User experience and feasibility of the blood pressure digital diary
Time Frame: 12 weeks
User experience and feasibility of the blood pressure digital diary assessed at Week 12 using the User Experience Questionnaire (UEQ)
12 weeks

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.
Closed Loop Medicine

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.
Pharmanovia

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: Serge Engamba, MD, Lead Principal Investigator

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.
April 15, 2024

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.
October 31, 2024

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.
October 31, 2024

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).
April 15, 2024

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.
April 15, 2024

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.
April 18, 2024

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.
March 20, 2026

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.
March 18, 2026

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.
March 1, 2026

More Information

Terms related to this study

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.
  • CLM-HTN-005

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

product manufactured in and exported from the U.S.

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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