MedDataX Logo

OptiZ: Real World Evidence Study

NCT ID: NCT06745726

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single cohort

N/A, this is an observational study.

Zestril

Intervention Type DRUG

N/A, this is an observational study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zestril

N/A, this is an observational study.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants must be 18 years or older.
2. Participants must have a diagnosis of essential hypertension.
3. 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
4. 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.
5. Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.

Exclusion Criteria

1. 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).
2. 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).
3. 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).
4. Failure to satisfy the responsible healthcare professional of fitness to participate for any other reason.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Closed Loop Medicine

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oak Street Medical Practice

Norwich, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Izabela Pilecka, PhD

Role: CONTACT

Phone: ‭07706374559‬

Email: [email protected]

Nihal Noori, MSc

Role: CONTACT

Phone: 07443603405

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Serge Engamba, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLM-HTN-006

Identifier Type: -

Identifier Source: org_study_id