OptiZ: Real World Evidence Study

NCT06745726 | Withdrawn

• 1 other identifier: CLM-HTN-006
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

Hypertension; Zestril; lisinopril; mHealth; mobile app; self-monitoring; personalised medicine; blood pressure control; home blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

  The change in systolic blood pressure from baseline to the end of the titration period.

  12 months

Secondary Outcomes (12)

• Mean change in diastolic blood pressure

  12 months

• Number and percentage of participants achieving target Home Blood Pressure at the end of their titration period

  12 months

• Median time from baseline to first achieving Home Blood Pressure control

  12 months

• Participants' daily adherence to Zestril

  12 months

• Adherence to collecting data using the OptiZ App

  12 months

Study Arms (1)

Single cohort

N/A, this is an observational study.

Drug: Zestril

Interventions

Zestril DRUG

N/A, this is an observational study.

Single cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Uncomplicated primary hypertension cohort in England

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Closed Loop Medicine: lead

Study Sites (1)

Oak Street Medical Practice

Norwich, NR3 3DL, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)