Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Net change in systolic blood pressure from baseline to 3 months follow-up
研究概览
简要总结
To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged more than 18 years old, less than or equal to 75 years old.
- •Hypertensive patients (systolic/diastolic blood pressure ≥140/90 mmHg at two separate screening/baseline visits)
- •Patients or guardians can skillfully use devices such as smartphones and electronic sphygmomanometers
- •Voluntarily joined and signed the informed consent
排除标准
- •Pregnant women or women planning to become pregnant within the next year;
- •Patients with secondary hypertension
- •Patients with life expectancy less than 1 year
- •Severe hepatic and renal insufficiency (ALT > 5 times ULA, eGFR < 15ml/min/1.73mm2)
- •Known active malignancy disease
- •The researcher believes that patients who are not suitable to participate in this study
结局指标
主要结局
Net change in systolic blood pressure from baseline to 3 months follow-up
时间窗: one and three months after study
次要结局
- Net change in diastolic blood pressure(one and three months after study)
- Hypertension control ratio (BP < 140/90 mmHg)(one and three months after study)
研究者
Hou Lei
Director of cardiovascular disease institute
Shanghai Tong Ren Hospital