NCT02391142Unknown不适用
Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic Heart Failure.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 years old
- •more than 3 months of chronic heart failure history or clinical symptoms of heart failure last for more than 3 months (including acute episode of chronic heart failure), chronic heart failure diagnostic criteria refer to 2012ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
- •NYHA functional class III-IV, ejection fraction ≤45%
- •NT-proBNP>400ng/L
排除标准
- •first episode of acute heart failure
- •unrepaired valvular heart disease accompanied with Hemodynamic changes
- •hypertrophic cardiomyopathy, pericardial disease, congenital heart disease, severe pulmonary hypertension
- •Second-degree type 2 or worse sinoatrial or atrioventricular block without pacemaker therapy
- •right heart failure caused by various diseases, respiratory failure or right heart failure induced by chronic obstructive pulmonary disease
- •overt renal decompensation: serum creatinine>2.1mg/dl(186umol/L)
- •severe hepatic dysfunction, transaminase or alkaline phosphatase > 3 times the upper limit of normal
- •Cerebral vascular accident in three months( cerebral infarction, cerebral embolism, cerebral hemorrhage,etc)
- •life expectancy shorter than 6 months
- •patients with a previous or present history of tumour or precancerous lesions confirmed by pathological examination
- •Spine Deformity or skin infection at puncture site
- •participate in any clinical drug trials in the three months
- •the patients who do not sign the informed consent, unable or unwilling to comply with the requirements of the protocol or unsuitable for the study
研究组 & 干预措施
cardiac sympathetic nerve block
Experimental
lidocaine or ropivacaine epidural injection
干预措施: Lidocaine (Drug)
结局指标
主要结局
All cause mortality
时间窗: one year
次要结局
- Rehospitalization rate(one year)
研究者
研究点 (1)
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