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OpenTrials
Completed

NCT Number: NCT06372470

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwich Health Centre

Norwich, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Zestril

Other

N/A, this is an observational study.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reduction in systolic blood pressure (SBP)

    Time frame: 12 weeks

    Mean change in SBP from baseline to the end of study Week 12

  2. Reduction in diastolic blood pressure (DBP)

    Time frame: 12 weeks

    Mean change in DBP from baseline to the end of study Week 12

  3. The time to achieve BP Control (BPC)

    Time frame: 12 weeks

    Median time from baseline to first achieving HBP control

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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)

  9. 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)

Sponsors and collaborators

Lead sponsor

Closed Loop Medicine

Industry

Collaborators

  • Pharmanovia

Registry information

Acronym: OptiZest

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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