Uncomplicated Hypertension Clinical Trial
— OptiZestOfficial title:
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
| NCT number | NCT06372470 |
| Other study ID # | CLM-HTN-005 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 15, 2024 |
| Est. completion date | August 31, 2024 |
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
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | August 31, 2024 |
| Est. primary completion date | August 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Norwich Health Centre | Norwich |
| Lead Sponsor | Collaborator |
|---|---|
| Closed Loop Medicine | Pharmanovia |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Reduction in systolic blood pressure (SBP) | Mean change in SBP from baseline to the end of study Week 12 | 12 weeks | |
| Secondary | Reduction in diastolic blood pressure (DBP) | Mean change in DBP from baseline to the end of study Week 12 | 12 weeks | |
| Secondary | The time to achieve BP Control (BPC) | Median time from baseline to first achieving HBP control | 12 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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