Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Heart Failure Due to Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07725484

Run by

Shanghai Zhongshan Hospital

People needed

1526

Starts

2026-11-01

Expected to finish

2030-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei, Anhui, China
• Fujian provincial hospital — Fuzhou, Fujian, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Luoyang Central Hospital Affiliated to Zhengzhou University — Luoyang, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China
• Affiliated Zhongshan Hospital of Dalian University — Dalian, Liaoning, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• Affiliated Hospital of Jining Medical University — Jining, Shandong, China
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• Shanghai East Hospital, Tongji University School of Medicine — Shanghai, Shanghai Municipality, China
• Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital — Shanghai, Shanghai Municipality, China
• Wusong Hospital, Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China
• The Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China
• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China
• Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University) — Quzhou, Zhejiang, China
• The First Affiliated Hospital of Dalian Medical University — Dalian, China
• Guangdong Provincial People's Hospital — Guangdong, China

Full record on ClinicalTrials.gov

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