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

NCT06068166 | Completed

• 1 other identifier: TEA
• Study Type: interventional
• Target: 1,840
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Thoracic Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• Rate of heart failure mortality in the patients with HFrEF

  Rate of heart failure mortality in the patients with HFrEF

  8.5 years

Secondary Outcomes (1)

• Rate of heart failure rehospitalization in the patients with HFrEF

  8.5 years

Study Arms (2)

GDMT plus TEA

EXPERIMENTAL

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.

Combination Product: TEA plus GDMT

GDMT

ACTIVE COMPARATOR

The patients received maximally tolerated GDMT.

Drug: GDMT

Interventions

TEA plus GDMT COMBINATION_PRODUCT

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).

GDMT plus TEA

GDMT DRUG

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

GDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: July 1, 2013
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2023-09