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Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

4 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1526

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Dalian, Chine
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Guangdong, Chine
        • Guangdong Provincial People's Hospital
        • Contact:
    • Anhui
      • Hefei, Anhui, Chine, 230001
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Contact:
    • Fujian
      • Fuzhou, Fujian, Chine, 35000
        • Fujian Provincial Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Henan
      • Luoyang, Henan, Chine, 471009
        • Luoyang Central Hospital Affiliated to Zhengzhou University
        • Contact:
          • Xuewei Chang
          • Numéro de téléphone: +86-379-63892222
          • E-mail: xueway@126.com
      • Zhengzhou, Henan, Chine, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210009
        • Zhongda Hospital, Southeast University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, Chine
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, Chine, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Jinan, Shandong, Chine, 250012
        • Qilu Hospital of Shandong University
        • Contact:
          • Xiaoping Ji
          • Numéro de téléphone: +86-531-82169400
          • E-mail: jxp64@163.com
      • Jining, Shandong, Chine, 272029
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Qingdao, Shandong, Chine, 266000
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Wenzhong Zhang
          • Numéro de téléphone: +86-532-96166
          • E-mail: xxmczwz@163.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200032
      • Shanghai, Shanghai Municipality, Chine, 200120
        • Shanghai East Hospital, Tongji University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, Chine, 200237
        • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, Chine, 200940
        • Wusong Hospital, Zhongshan Hospital, Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, Chine, 201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, Chine, 030024
        • Shanxi Cardiovascular Hospital
        • Contact:
      • Taiyuan, Shanxi, Chine, 030001
        • The Second Hospital of Shanxi Medical University
        • Contact:
    • Zhejiang
      • Quzhou, Zhejiang, Chine, 324000
        • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: groupe placebo
Médicament: placebo
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
Expérimental: Alpha-Lipoic Acid (ALA)
Médicament: Alpha-Lipoic Acid (ALA)
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Major Adverse Cardiovascular Events (MACE)
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Hospitalization for Heart Failure
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Zhongshan Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 novembre 2030

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

21 juillet 2026

Première soumission répondant aux critères de contrôle qualité

21 juillet 2026

Première publication (Réel)

24 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2026037

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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