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

Not Applicable

• Conditions: Heart Failure
• Interventions: Drug: Lidocaine

• Registration Number: NCT02391142
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-06
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cardiac sympathetic nerve block	Lidocaine	lidocaine or ropivacaine epidural injection

Primary Outcome Measures

Name	Time	Method
All cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
Rehospitalization rate	one year

Trial Locations

Locations (1)

the First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China