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Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

2026년 8월 4일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1526

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 그룹
의약품: placebo
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
실험적: Alpha-Lipoic Acid (ALA)
의약품: Alpha-Lipoic Acid (ALA)
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Major Adverse Cardiovascular Events (MACE)
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Hospitalization for Heart Failure
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Zhongshan Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2030년 11월 1일

연구 완료 (추정된)

2030년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 21일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 4일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KY2026037

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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