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

NCT02391142 | Unknown

• 1 other identifier: CSB-CHF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; cardiac sympathetic nerve block; sympathetic nervous system

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  one year

Secondary Outcomes (1)

• Rehospitalization rate

  one year

Study Arms (2)

cardiac sympathetic nerve block

EXPERIMENTAL

lidocaine or ropivacaine epidural injection

Drug: Lidocaine

non-cardiac sympathetic nerve block

NO INTERVENTION

Interventions

Lidocaine DRUG

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

Also known as: ropivacaine

cardiac sympathetic nerve block

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Fengqi Liu, PhD

CONTACT

86-451-85555241; fengqiliu1964@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 8, 2018

Record last verified: 2014-05

Locations

CN (1)