Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure (CSB-CHF)

Harbin Medical University

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02391142

CSB-CHF

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

cardiac sympathetic nerve block

Experimental group

Description:

lidocaine or ropivacaine epidural injection

Treatment:

Drug: Lidocaine

non-cardiac sympathetic nerve block

No Intervention group