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

Heart Failure Clinical Trial

— CSB-CHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391142
• Other study ID #: CSB-CHF
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: January 2019

Study information

• Verified date: May 2014
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Fengqi Liu, PhD
• Phone: 86-451-85555241
• Email: fengqiliu1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Lidocaine
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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		one year
Secondary	Rehospitalization rate		one year