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临床试验/NCT02282618
NCT02282618Unknown不适用

Effects of Cardiac Sympathetic Blockade in Patients With Chronic Heart Failure, a 2-year, Prospective, Randomized Cohort Study

Harbin Medical University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1
主要终点
mortality

研究概览

简要总结

Although current pharmaceutical therapies have improved the survival rate in heart failure it remains a fatal disease and is associated with a poor 3-year survival. Increased sympathetic activity found in patients with heart failure plays an important role in the pathogenesis and development of the disease[Provide reference]. Excessive activation of sympathetic tone contributes to arrhythmogenesis, increased cardiac wall tension, and platelet aggregation, promoting a "vicious cycle[What cycle? Elaborate. ]" in these patients.

High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has accumulated clinical experiences from thousands of cases. His anecdotal experience indicates that the method can favorably improve intractable angina, dilated cardiomyopathy, and advanced heart failure. Though the method has been used to treat patients at our center for many years, there has been no prospective trial of its effects on cardiovascular function, or its efficacy to improve clinical outcomes.

The investigators propose to investigate the immediate physiologic effect and clinical effectiveness of HTEA in treating heart failure.

详细描述

Although current pharmaceutical therapies have improved the survival rate in heart failure it remains a fatal disease and is associated with a poor 3-year survival. Increased sympathetic activity found in patients with heart failure plays an important role in the pathogenesis and development of the disease[Provide reference]. Excessive activation of sympathetic tone contributes to arrhythmogenesis, increased cardiac wall tension, and platelet aggregation, promoting a "vicious cycle[What cycle? Elaborate. ]" in these patients.

High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has accumulated clinical experiences from thousands of cases. His anecdotal experience indicates that the method can favorably improve intractable angina, dilated cardiomyopathy, and advanced heart failure. Though the method has been used to treat patients at our center for many years, there has been no prospective trial of its effects on cardiovascular function, or its efficacy to improve clinical outcomes.

The investigators propose to investigate the immediate physiologic effect and clinical effectiveness of HTEA in treating heart failure.

Methods and design The investigators propose a double-blind placebo-controlled clinical trial. 230 chronic heart failure patients with the course of more than three months will be randomly allocated two groups, 90 in HTEA group, 90 in sham-HTEA (SHAM) group. The investigators will compare their outcomes to 50 historical controls (CON). Ethical approval from our institutional review board will be obtained. Patients will be consented appropriately, and be free to withdraw from the study at any time.

According to the guidelines for chronic heart failure treatment, diuretics, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, aldosterone receptor antagonists, digitalis, and vasodilating agents should be used as standard treatments for heart failure in the three groups.

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
17 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic heart failure patients with the course of more than three months.

排除标准

  • Vavular heart diseases.

结局指标

主要结局

mortality

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Harbin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Liu

Prof.

Harbin Medical University

研究点 (1)

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