Clinical Assessment of the Treatment With Cardiac Sympath... | NCT02391142

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

NCT02391142

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Unknown status

Last Update Posted

Aug 8, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Lidocaine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Mar 12, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac sympathetic nerve block	Experimental	lidocaine or ropivacaine epidural injection	Drug: Lidocaine
non-cardiac sympathetic nerve block	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	cardiac sympathetic nerve block

Measure	Description	Time Frame
All cause mortality		one year

Measure	Description	Time Frame
Rehospitalization rate		one year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D008012	Lidocaine
D000077212	Ropivacaine

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814