Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in the treatment of essential hypertension.
详细描述
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 on blood pressure patients with essential hypertension.
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
- Double (Participant, Outcomes Assessor)
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
- •Age≥18 years, regardless of sex;
- •Patients with systolic blood pressure ≥140mmHg with or without taking oral antihypertensive drugs
- •Signed and dated informed consent is obtained
排除标准
- •Secondary hypertension;
- •Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
- •Severe organ dysfunction or failure;
- •Severe hematologic disorders or significant coagulation abnormalities;
- •History of atrial fibrillation or myocardial infarction within 6 months;
- •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;
- •Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; ;
- •Pregnant or lactating women;
- •Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
- •Other conditions that the researchers think are not suitable for the project.
研究组 & 干预措施
RIC group
Patients are treated with remote ischemic conditioning (RIC).
干预措施: Remote ischemic conditioning (Procedure)
Sham RIC group
Patients are treated with sham remote ischemic conditioning (sham-RIC).
干预措施: Sham remote ischemic conditioning (Procedure)
结局指标
主要结局
Mean systolic blood pressure
时间窗: 1-7 days
Difference in mean systolic blood pressure during RIC/sham-RIC between two groups.
次要结局
- Mean diastolic blood pressure(1-7 days)
研究者
Yi Yang
Associated Dean of The First Hospital of Jilin University
The First Hospital of Jilin University