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

NCT ID: NCT02391142

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cardiac sympathetic nerve block

lidocaine or ropivacaine epidural injection

Group Type EXPERIMENTAL

Lidocaine

Intervention Type 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

non-cardiac sympathetic nerve block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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ropivacaine

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fengqi Liu, PhD

Role: CONTACT

86-451-85555241

Facility Contacts

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Fengqi Liu

Role: primary

86-0451-85555241

Dan Ma

Role: backup

86-0451-85555240

Other Identifiers

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CSB-CHF

Identifier Type: -

Identifier Source: org_study_id

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