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)

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: Completed
• Conditions: Uncomplicated Hypertension
• Intervention / Treatment: Other: Zestril

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Norwich, United Kingdom
    • Norwich Health Centre

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Arm; Single cohort	Other: Zestril; N/A, this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in systolic blood pressure (SBP)	Mean change in SBP from baseline to the end of study Week 12	12 weeks
Reduction in diastolic blood pressure (DBP)	Mean change in DBP from baseline to the end of study Week 12	12 weeks
The time to achieve BP Control (BPC)	Median time from baseline to first achieving HBP control	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	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	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)	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	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)	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)	12 weeks

Collaborators and Investigators

• Sponsor: Closed Loop Medicine
• Collaborators: Pharmanovia
• Investigators: Principal Investigator: Serge Engamba, MD, Lead Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Dipeptides; Lisinopril
• Other Study ID 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