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临床试验/NCT06068166
NCT06068166已完成不适用

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

First Affiliated Hospital of Harbin Medical University0 个研究点目标入组 1,840 人开始时间: 2013年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,840
主要终点
Rate of heart failure mortality in the patients with HFrEF

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: TEA plus GDMT (Combination Product)

GDMT

Active Comparator

The patients received maximally tolerated GDMT.

干预措施: GDMT (Drug)

结局指标

主要结局

Rate of heart failure mortality in the patients with HFrEF

时间窗: 8.5 years

Rate of heart failure mortality in the patients with HFrEF

次要结局

  • Rate of heart failure rehospitalization in the patients with HFrEF(8.5 years)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

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