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 (OptiZest)

Closed Loop Medicine

Status: Completed

Conditions: Uncomplicated Hypertension

Treatments: Other: Zestril

Study type: Observational

Funder types: Industry

Identifiers

NCT06372470

CLM-HTN-005

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Study Arm

Description:

Single cohort

Treatment:

Other: Zestril