MedDataX Logo

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 ID: NCT06372470

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-11-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uncomplicated Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Arm

Single cohort

Zestril

Intervention Type OTHER

N/A, this is an observational study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zestril

N/A, this is an observational study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pharmanovia

INDUSTRY

Sponsor Role collaborator

Closed Loop Medicine

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Serge Engamba

Role: PRINCIPAL_INVESTIGATOR

Lead Principal Investigator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Norwich Health Centre

Norwich, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLM-HTN-005

Identifier Type: -

Identifier Source: org_study_id