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Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

4 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1526

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
      • Dalian, Porcelana
        • The First Affiliated Hospital of Dalian Medical University
        • Contacto:
      • Guangdong, Porcelana
        • Guangdong Provincial People's Hospital
        • Contacto:
          • Liwen Li
          • Número de teléfono: 020-83827812
          • Correo electrónico: gdghllw@163.com
    • Anhui
      • Hefei, Anhui, Porcelana, 230001
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Contacto:
          • Kangyu Chen
          • Número de teléfono: +86-551-62283114
          • Correo electrónico: ahslyycky@126.com
    • Fujian
      • Fuzhou, Fujian, Porcelana, 35000
        • Fujian Provincial Hospital
        • Contacto:
          • Yansong Guo
          • Número de teléfono: 0591-87557768
          • Correo electrónico: ysguo1234@126.com
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contacto:
    • Henan
      • Luoyang, Henan, Porcelana, 471009
        • Luoyang Central Hospital Affiliated to Zhengzhou University
        • Contacto:
          • Xuewei Chang
          • Número de teléfono: +86-379-63892222
          • Correo electrónico: xueway@126.com
      • Zhengzhou, Henan, Porcelana, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Contacto:
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210009
        • Zhongda Hospital, Southeast University
        • Contacto:
    • Liaoning
      • Dalian, Liaoning, Porcelana
        • Affiliated Zhongshan Hospital of Dalian University
        • Contacto:
          • Qin Yu
          • Número de teléfono: 0411-62893000
          • Correo electrónico: yuqin@dlu.edu.cn
    • Shaanxi
      • Xi'an, Shaanxi, Porcelana, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contacto:
    • Shandong
      • Jinan, Shandong, Porcelana, 250012
        • Qilu Hospital of Shandong University
        • Contacto:
          • Xiaoping Ji
          • Número de teléfono: +86-531-82169400
          • Correo electrónico: jxp64@163.com
      • Jining, Shandong, Porcelana, 272029
        • Affiliated Hospital of Jining Medical University
        • Contacto:
      • Qingdao, Shandong, Porcelana, 266000
        • The Affiliated Hospital of Qingdao University
        • Contacto:
          • Wenzhong Zhang
          • Número de teléfono: +86-532-96166
          • Correo electrónico: xxmczwz@163.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200032
        • Zhongshan hospital, Fudan university
        • Contacto:
      • Shanghai, Shanghai Municipality, Porcelana, 200120
        • Shanghai East Hospital, Tongji University School of Medicine
        • Contacto:
      • Shanghai, Shanghai Municipality, Porcelana, 200237
        • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital
        • Contacto:
      • Shanghai, Shanghai Municipality, Porcelana, 200940
        • Wusong Hospital, Zhongshan Hospital, Fudan University
        • Contacto:
      • Shanghai, Shanghai Municipality, Porcelana, 201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Contacto:
    • Shanxi
      • Taiyuan, Shanxi, Porcelana, 030024
        • Shanxi Cardiovascular Hospital
        • Contacto:
          • Xiurui Ma
          • Número de teléfono: +86-351-5275550
          • Correo electrónico: 1234maer@163.com
      • Taiyuan, Shanxi, Porcelana, 030001
        • The Second Hospital of Shanxi Medical University
        • Contacto:
    • Zhejiang
      • Quzhou, Zhejiang, Porcelana, 324000
        • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: grupo placebo
Droga: placebo
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
Experimental: Alpha-Lipoic Acid (ALA)
Droga: Alpha-Lipoic Acid (ALA)
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospitalization for Heart Failure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai Zhongshan Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2030

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KY2026037

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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