Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Changes of mean systolic blood pressure
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
详细描述
At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥30 years, ≤ 75 years, regardless of sex;
- •Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
- •Signed and dated informed consent is obtained.
排除标准
- •Blood pressure ≥ 180/110mmHg;
- •Planned adjustment of antihypertensive drugs within the next 3 weeks;
- •Severe hematologic disorders or significant coagulation abnormalities;
- •Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- •Pregnant or lactating women;
- •Severe hepatic and renal dysfunction;
- •Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
- •Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
研究组 & 干预措施
RIC group
Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.
干预措施: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning. (Device)
Control group
Patients are only treated with previous antihypertensive treatment.
干预措施: Previous antihypertensive treatment (Other)
结局指标
主要结局
Changes of mean systolic blood pressure
时间窗: 12-14 days
The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure
次要结局
- Mean systolic blood pressure level(12-14 days)
- Blood pressure compliance rate(15-28 days)
- Changes of mean diastolic blood pressure(12-14 days)
- Mean diastolic blood pressure level(12-14 days)
- Blood pressure target achievement rate(14 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University