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Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

2026年8月4日 更新者：Xu Lei、Shanghai Zhongshan Hospital

Lipoic Acid in Chronic Ischemic Heart Failure: Assessment of Reduction in Major Adverse Cardiovascular Events

Chronic heart failure is a clinical condition caused by structural heart disease and is characterized by reduced pumping function, fluid retention, and abnormal activation of neurohormonal systems. It represents the advanced stage of many cardiovascular diseases and remains a major global health challenge. Despite progress in medical and interventional therapies, patients with chronic heart failure continue to experience high rates of death, hospitalization, and long-term disability.

Ischemic heart failure, which develops as a result of coronary artery disease and prior myocardial infarction, is the most common form of chronic heart failure. Current treatment strategies, including guideline-directed medical therapy and revascularization procedures, can improve symptoms and outcomes but do not fully address the residual risk of adverse cardiovascular events. Therefore, additional therapeutic approaches are needed to further improve long-term prognosis in this population.

Abnormal myocardial energy metabolism is a key pathological feature of heart failure. Mitochondria play a central role in energy production, and impaired mitochondrial function contributes to disease progression. Previous studies by our group have identified mitochondrial aldehyde dehydrogenase 2 (ALDH2) as an important regulator of myocardial metabolic homeostasis and cardiac protection under ischemic and stress conditions.

Alpha-lipoic acid is a vitamin B-related compound with antioxidant properties and has been widely used in clinical practice for other indications. Increasing evidence suggests that alpha-lipoic acid may also exert protective effects in cardiovascular diseases, potentially through modulation of mitochondrial function. Experimental studies have shown that alpha-lipoic acid can restore ALDH2 activity and improve cardiac function in models of heart failure.

Based on these findings, we conducted an exploratory randomized controlled trial between 2019 and 2023 to evaluate the safety and potential efficacy of alpha-lipoic acid in patients with ischemic heart failure. In this multicenter study, patients receiving alpha-lipoic acid showed favorable trends toward reduced risk of death and heart failure-related hospitalization, as well as significant improvements in left ventricular ejection fraction and exercise capacity, without an increase in adverse events.

Taken together, prior mechanistic research and early clinical evidence support the hypothesis that alpha-lipoic acid may provide additional benefit when used as adjunctive therapy in patients with chronic ischemic heart failure. The present study is designed to further evaluate whether long-term supplementation with alpha-lipoic acid can reduce major adverse cardiovascular events and improve clinical outcomes in this population.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1526

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Dalian、中国
        • The First Affiliated Hospital of Dalian Medical University
        • 接触：
      • Guangdong、中国
        • Guangdong Provincial People's Hospital
        • 接触：
    • Anhui
      • Hefei、Anhui、中国、230001
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国、35000
        • Fujian Provincial Hospital
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国、510080
        • The First Affiliated Hospital, Sun Yat-sen University
        • 接触：
    • Henan
      • Luoyang、Henan、中国、471009
        • Luoyang Central Hospital Affiliated to Zhengzhou University
        • 接触：
          • Xuewei Chang
          • 电话号码：+86-379-63892222
          • 邮箱：xueway@126.com
      • Zhengzhou、Henan、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
        • 接触：
    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • Zhongda Hospital, Southeast University
        • 接触：
    • Liaoning
      • Dalian、Liaoning、中国
        • Affiliated Zhongshan Hospital of Dalian University
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
    • Shandong
      • Jinan、Shandong、中国、250012
        • Qilu Hospital of Shandong University
        • 接触：
          • Xiaoping Ji
          • 电话号码：+86-531-82169400
          • 邮箱：jxp64@163.com
      • Jining、Shandong、中国、272029
        • Affiliated Hospital of Jining Medical University
        • 接触：
      • Qingdao、Shandong、中国、266000
        • The Affiliated Hospital of Qingdao University
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
      • Shanghai、Shanghai Municipality、中国、200120
        • Shanghai East Hospital, Tongji University School of Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200237
        • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200940
        • Wusong Hospital, Zhongshan Hospital, Fudan University
        • 接触：
      • Shanghai、Shanghai Municipality、中国、201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • 接触：
    • Shanxi
      • Taiyuan、Shanxi、中国、030024
        • Shanxi Cardiovascular Hospital
        • 接触：
      • Taiyuan、Shanxi、中国、030001
        • The Second Hospital of Shanxi Medical University
        • 接触：
    • Zhejiang
      • Quzhou、Zhejiang、中国、324000
        • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 18 years or older and younger than 75 years at the time of enrollment.
  • A history of chronic heart failure for more than 3 months, or clinical symptoms of heart failure lasting more than 3 months, diagnosed according to the 2023 European Society of Cardiology guidelines for the diagnosis and treatment of chronic heart failure.
  • Left ventricular ejection fraction (LVEF) of 40% or less, as assessed by echocardiography.
  • A history of acute myocardial infarction more than 3 months prior to enrollment, diagnosed according to the Fourth Universal Definition of Myocardial Infarction.
  • New York Heart Association (NYHA) functional class II to IV, with stable clinical symptoms.
  • Receipt of guideline-directed medical therapy for heart failure for at least 2 weeks, without dose adjustment or intravenous therapy during this period. Guideline-directed medical therapy includes: Angiotensin-converting enzyme inhibitors (ACEIs), or Angiotensin receptor blockers (ARBs), or Angiotensin receptor-neprilysin inhibitors (ARNIs), Beta-blockers, and Mineralocorticoid receptor antagonists,unless contraindicated or not tolerated, and prescribed at optimal tolerated doses.
  • Ability and willingness to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Prior cardiac resynchronization therapy (CRT).
  • Severe hepatic dysfunction, defined as liver transaminase levels greater than three times the upper limit of normal, or severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
  • Presence of uncontrolled malignant arrhythmias or progressively worsening unstable angina.
  • Presence of malignancy, lymphoma, leukemia, or other serious diseases with an expected life expectancy of less than 1 year.
  • Participation in another investigational drug study within 4 weeks prior to enrollment, or current receipt of any investigational treatment other than the study intervention.
  • Pregnant or breastfeeding women.
  • Known allergy to vitamin B-related medications.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂组
药品：placebo
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
实验性的：Alpha-Lipoic Acid (ALA)
药品：Alpha-Lipoic Acid (ALA)
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Major Adverse Cardiovascular Events (MACE)
大体时间：From enrollment to the end of treatment at 24 months.
Major adverse cardiovascular events (MACE) are defined as a composite outcome that includes cardiovascular death, hospitalization for heart failure, non-fatal stroke, and non-fatal myocardial infarction occurring during the follow-up period. The primary outcome is the occurrence of the first MACE event during follow-up, identified using standard clinical criteria and confirmed through medical records.
From enrollment to the end of treatment at 24 months.
Hospitalization for Heart Failure
大体时间：From enrollment to the end of treatment at 24 months.
Unplanned admission to the hospital due to worsening heart failure symptoms that require intravenous treatment or intensified medical care during follow-up.
From enrollment to the end of treatment at 24 months.

次要结果测量

结果测量
措施说明
大体时间
Hospitalization for Heart Failure
大体时间：From enrollment to the end of treatment at 24 months.
Unplanned hospitalization due to worsening heart failure symptoms occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Non-fatal Stroke
大体时间：From enrollment to the end of treatment at 24 months.
A new stroke event that does not result in death, diagnosed based on clinical symptoms and imaging findings, occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Non-fatal Myocardial Infarction
大体时间：From enrollment to the end of treatment at 24 months.
A new myocardial infarction that does not result in death, diagnosed according to standard clinical criteria, occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
All-cause Mortality
大体时间：From enrollment to the end of treatment at 24 months.
Death from any cause occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Change in Left Ventricular Ejection Fraction (LVEF)
大体时间：From enrollment to the end of treatment at 24 months.
Change in left ventricular ejection fraction from baseline to 24 months after randomization, measured by echocardiography.
From enrollment to the end of treatment at 24 months.
Change in 6-Minute Walk Distance (6MWD)
大体时间：From enrollment to the end of treatment at 24 months.
Change in the distance walked during the 6-minute walk test from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Change in NT-proBNP Level
大体时间：From enrollment to the end of treatment at 24 months.
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Change in Quality of Life Score (KCCQ)
大体时间：From enrollment to the end of treatment at 24 months.
Change in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Unplanned Coronary Revascularization
大体时间：From enrollment to the end of treatment at 24 months.
Unplanned coronary revascularization due to acute myocardial ischemia during follow-up, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This outcome is defined as a binary event.
From enrollment to the end of treatment at 24 months.
Heart Transplantation
大体时间：From enrollment to the end of treatment at 24 months.
Occurrence of orthotopic heart transplantation performed as definitive treatment for end-stage heart failure during the follow-up period. This outcome is defined as a binary event.
From enrollment to the end of treatment at 24 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Zhongshan Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2030年11月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月21日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KY2026037

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Deidentified individual participant data will not be made publicly available because the study includes sensitive clinical and genetic information, and no mechanism or participant consent for sharing data with external researchers has been established. Aggregate study results will be disseminated through ClinicalTrials.gov and peer-reviewed publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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