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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac sympathetic nerve block, sympathetic nervous system

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • the First Affiliated Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cardiac sympathetic nerve block

non-cardiac sympathetic nerve block

Arm Description

lidocaine or ropivacaine epidural injection

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Rehospitalization rate

Full Information

First Posted
March 12, 2015
Last Updated
August 7, 2018
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02391142
Brief Title
Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
Acronym
CSB-CHF
Official Title
Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, cardiac sympathetic nerve block, sympathetic nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cardiac sympathetic nerve block
Arm Type
Experimental
Arm Description
lidocaine or ropivacaine epidural injection
Arm Title
non-cardiac sympathetic nerve block
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
ropivacaine
Intervention Description
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
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
Rehospitalization rate
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengqi Liu, PhD
Phone
86-451-85555241
Email
fengqiliu1964@163.com
Facility Information:
Facility Name
the First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengqi Liu
Phone
86-0451-85555241
Email
fengqiliu1964@163.com
First Name & Middle Initial & Last Name & Degree
Dan Ma
Phone
86-0451-85555240
Email
madandoc@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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