Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction：a Retrospective Matched Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068166
• Other study ID #: TEA
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF.

Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1840
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) =40%, who were hospitalized from July 2013 to August 2019.

Exclusion Criteria:

• Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Thoracic Epidural Anesthesia

Intervention

Combination Product:
• TEA plus GDMT
Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. All the patients received maximally tolerated guideline-directed medical therapy (GDMT).

Drug:
• GDMT
All the patients received maximally tolerated guideline-directed medical therapy (GDMT) alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of heart failure mortality in the patients with HFrEF	Rate of heart failure mortality in the patients with HFrEF	8.5 years
Secondary	Rate of heart failure rehospitalization in the patients with HFrEF	Rate of heart failure rehospitalization in the patients with HFrEF	8.5 years