Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncomplicated Hypertension
Lead sponsor: Closed Loop Medicine
Sponsor class: INDUSTRY
Collaborators: name: Pharmanovia
First posted: 2024-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uncomplicated primary hypertension cohort in England

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


Eligibility criteria: 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.

Primary outcomes:
measure: Achieving target Home Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in systolic blood pressure (SBP)
timeFrame: 12 weeks
measure: Reduction in diastolic blood pressure (DBP)
timeFrame: 12 weeks
measure: The time to achieve BP Control (BPC)
timeFrame: 12 weeks
measure: Patient daily adherence to prescribed medication
timeFrame: 12 weeks
measure: Adherence to collecting data using the electronic BP diary
timeFrame: 12 weeks
measure: Patients' thoughts and feelings about BP/treatment
timeFrame: 12 weeks
measure: Discontinuation of Zestril due to unwanted side effects
timeFrame: 12 weeks
measure: Number and type of spontaneously reported unwanted side effects
timeFrame: 12 weeks
measure: User experience and feasibility of the blood pressure digital diary
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norwich Health Centre
Study officials:
affiliation: Lead Principal Investigator
name: Serge Engamba
role: PRINCIPAL_INVESTIGATOR
References: