Not Yet RecruitingPhase 3

Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

China1,526 participantsStarted 2026-11-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 rena…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing lipoic acid on top of whatever standard heart failure treatment I'm already on — can you explain what lipoic acid is supposed to do for ischemic heart failure, and whether there's any early evidence suggesting it might help?
2Since this trial is Phase 3 and focused on serious outcomes like major cardiovascular events and hospitalizations, what does that phase tell us about how much is already known about its safety, and are there any risks specific to lipoic acid I should be aware of?
3The trial isn't recruiting yet — given that my condition is heart failure due to coronary artery disease, would it make more sense for me to pursue my current standard treatment plan now rather than waiting to see if this trial opens, or could both happen at the same time?
4When this trial does open, what would participation actually look like day-to-day — how often would I need to come in for visits, and is that realistic given my current health and situation?
5Are there other trials or treatment options already available that are also measuring heart failure hospitalizations and major cardiac events, so I can compare whether waiting for this study to open is worth it?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major Adverse Cardiovascular Events (MACE)

Timeframe: From enrollment to the end of treatment at 24 months.

Hospitalization for Heart Failure

Timeframe: From enrollment to the end of treatment at 24 months.

Trial details

NCT IDNCT07725484

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-11-01

Contact for this trial

Aijun Sun

021-64041990 sun.aijun@zs-hospital.sh.cn

View on ClinicalTrials.gov More Heart Failure Due to Coronary Artery Disease trials