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| Name | Class |
|---|---|
| Pharmanovia | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Single cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zestril | Other | N/A, this is an observational study. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Uncomplicated primary hypertension cohort in England
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| Name | Affiliation | Role |
|---|---|---|
| Serge Engamba, MD | Lead Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwich Health Centre | Norwich | United Kingdom |
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| 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 |
| ID | Term |
|---|---|
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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