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

NCT06372470 | Completed

• 1 other identifier: CLM-HTN-005
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reduction in systolic blood pressure (SBP)

  12 weeks

• Reduction in diastolic blood pressure (DBP)

  12 weeks

• The time to achieve BP Control (BPC)

  12 weeks

• Patient daily adherence to prescribed medication

  12 weeks

• Adherence to collecting data using the electronic BP diary

  12 weeks

Study Arms (1)

Study Arm

Single cohort

Other: Zestril

Interventions

Zestril OTHER

N/A, this is an observational study.

Study Arm

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Closed Loop Medicine: lead
• Pharmanovia: collaborator

Study Sites (1)

Norwich Health Centre

Norwich, United Kingdom

Location

MeSH Terms

Interventions

Lisinopril

Intervention Hierarchy (Ancestors)

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

Study Officials

• Serge Engamba, MD

  Lead Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)