NCT02282618

Brief Summary

Although current pharmaceutical therapies have improved the survival rate in heart failure it remains a fatal disease and is associated with a poor 3-year survival. Increased sympathetic activity found in patients with heart failure plays an important role in the pathogenesis and development of the disease\[Provide reference\]. Excessive activation of sympathetic tone contributes to arrhythmogenesis, increased cardiac wall tension, and platelet aggregation, promoting a "vicious cycle\[What cycle? Elaborate. \]" in these patients. High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has accumulated clinical experiences from thousands of cases. His anecdotal experience indicates that the method can favorably improve intractable angina, dilated cardiomyopathy, and advanced heart failure. Though the method has been used to treat patients at our center for many years, there has been no prospective trial of its effects on cardiovascular function, or its efficacy to improve clinical outcomes. The investigators propose to investigate the immediate physiologic effect and clinical effectiveness of HTEA in treating heart failure.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

October 31, 2014

Last Update Submit

November 3, 2014

Conditions

Chronic Heart Failure

Keywords

Cardiac Sympathetic Blockade

Outcome Measures

Primary Outcomes (1)

  • mortality

    6 months

Study Arms (2)

heart failure with HTEA

Heart failure patients are treated with the world-wide accepted medicine, plus HTEA for 4 weeks.

heart failure with medicine

Heart failure patients are treated with the world-wide accepted medicine.

Device: Cardiac Sympathetic Blockade

Interventions

Cardiac Sympathetic BlockadeDEVICE
heart failure with medicine

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

heart failure

You may qualify if:

  • chronic heart failure patients with the course of more than three months.

You may not qualify if:

  • Vavular heart diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 4, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Last Updated

November 4, 2014

Record last verified: 2014-10

Locations

CN(1)