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

Not Applicable

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction; Thoracic Epidural Anesthesia
• Interventions: Drug: GDMT; Combination Product: TEA plus GDMT

• Registration Number: NCT06068166
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2019-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDMT	GDMT	The patients received maximally tolerated GDMT.
GDMT plus TEA	TEA plus GDMT	The patients received maximally tolerated guideline-directed medical therapy (GDMT) plus TEA. 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.

Primary Outcome Measures

Name	Time	Method
Rate of heart failure mortality in the patients with HFrEF	8.5 years	Rate of heart failure mortality in the patients with HFrEF

Secondary Outcome Measures

Name	Time	Method
Rate of heart failure rehospitalization in the patients with HFrEF	8.5 years	Rate of heart failure rehospitalization in the patients with HFrEF