NCT06372470已完成不适用
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
Closed Loop Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Achieving target Home Blood Pressure
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older.
- •Patients diagnosed with uncomplicated essential (primary) hypertension eligible for Zestril per SmPC for hypertension management.
- •Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
- •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.
排除标准
- •Clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment).
- •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).
- •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
- •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.
- •Any condition associated with poor compliance including alcoholism or drug dependence.
- •Participants with cognitive impairments or language barriers that hinder their ability to understand and comply with study instructions and e-questionnaires.
- •Failure to satisfy the investigator of fitness to participate for any other reason.
结局指标
主要结局
Achieving target Home Blood Pressure
时间窗: 12 weeks
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.
次要结局
- Reduction in systolic blood pressure (SBP)(12 weeks)
- Patients' thoughts and feelings about BP/treatment(12 weeks)
- Patient daily adherence to prescribed medication(12 weeks)
- Discontinuation of Zestril due to unwanted side effects(12 weeks)
- The time to achieve BP Control (BPC)(12 weeks)
- User experience and feasibility of the blood pressure digital diary(12 weeks)
- Reduction in diastolic blood pressure (DBP)(12 weeks)
- Number and type of spontaneously reported unwanted side effects(12 weeks)
- Adherence to collecting data using the electronic BP diary(12 weeks)
研究者
研究点 (1)
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