Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac sympathetic nerve block<br>lidocaine or ropivacaine epidural injection | Drug: Lidocaine<br>* 0.5% lidocaine 5ml epidural injection every 2 hours per day or 0.2% ropivacaine 5ml epidural injection every 4 hours per day, last for 4weeks<br>* Other names: ropivacaine;|
| No Intervention: non-cardiac sympathetic nerve block<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization rate |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardiac sympathetic nerve block, sympathetic nervous system