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Alpha-lipoic acid for long-term heart failure caused by coronary artery disease

Tests alpha-lipoic acid against placebo in adults with ischemic heart failure.

Key facts

Who runs it
Shanghai Zhongshan Hospital
Where
Dalian, Fuzhou, Guangdong, Guangzhou, Hangzhou, Hefei, Jinan, Jining, Luoyang, Nanjing, Qingdao, Quzhou, Shanghai, Taiyuan, Xi’an, and Zhengzhou, ChinaSee the 23 sites
Trial code
Registry title
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,188 people, planned
Started
1 Nov 2026
Expected to end
1 Dec 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Alpha-Lipoic Acid (ALA)
  • placebo
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-standing heart failure caused by coronary artery disease and an earlier heart attack. It tests alpha-lipoic acid against placebo.

Age
From 18 years up to under 75 years.
Sex
All sexes can join.
Disease stage
Heart failure for more than 3 months, heart pumping (LVEF) below 50%, NYHA class II-IV, and a heart attack more than 3 months before joining.
Earlier treatment
Must have received guideline-directed heart failure medicine for at least 2 weeks. Must not have had cardiac resynchronization therapy (CRT).
Biomarker or test result
Left ventricular ejection fraction (LVEF) below 50% on an echocardiogram.

Main reasons for not taking part

  • Severe liver or kidney problems (eGFR below 30 mL/min/1.73 m²)
  • Pregnant or breastfeeding women
  • Uncontrolled dangerous heart rhythm problems or worsening unstable angina
  • Cancer or another condition with life expectancy under 1 year
  • Heart failure caused by cardiomyopathy, myocarditis, pericarditis or primary valve disease

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Participants must meet all of the following criteria:
  • Aged ≥18 years and <75 years
  • A history of chronic heart failure for more than 3 months or clinically documented symptoms of heart failure persisting for more than 3 months
  • Left ventricular ejection fraction (LVEF) <50% as assessed by echocardiography
  • A history of acute myocardial infarction (AMI) more than 3 months prior to enrollment
  • New York Heart Association (NYHA) functional class II-IV
  • Receipt of guideline-directed medical therapy (GDMT) for at least 2 weeks
  • Willingness to participate in the study, with the ability to understand and provide written informed consent

Who cannot take part

  • Previous cardiac resynchronization therapy (CRT)
  • Participation in another investigational drug trial within 4 weeks prior to enrollment or ongoing receipt of any investigational treatment other than the study medication
  • Uncontrolled malignant arrhythmias or progressively worsening unstable angina
  • Malignancies, lymphoma, leukemia, or other serious conditions associated with a life expectancy of less than 1 year
  • Known hypersensitivity or allergy to vitamin B preparations
  • Heart failure caused by restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or primary valvular heart disease
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study
  • Severe hepatic dysfunction, defined as serum transaminase levels exceeding 3 times the upper limit of normal (ULN), or severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²
  • Participants meeting any of the following criteria will be excluded:
  • Pregnant or breastfeeding women
  • Hemodynamic instability

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Affiliated Zhongshan Hospital of Dalian UniversityDalian, ChinaContact: Qin YuNo longer taking part
  • The First Affiliated Hospital of Dalian Medical UniversityDalian, ChinaContact: Ying LiuNo longer taking part
  • Fujian Provincial HospitalFuzhou, ChinaContact: Yansong GuoNo longer taking part
  • Guangdong Provincial People'S HospitalGuangdong, ChinaContact: Liwen LiNo longer taking part
  • The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Chen LiuNo longer taking part
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Yan huiNo longer taking part
  • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)Hefei, ChinaContact: Kangyu ChenNo longer taking part
  • Qilu Hospital of Shandong UniversityJinan, ChinaContact: Xiaoping JiNo longer taking part
  • Affiliated Hospital of Jining Medical UniversityJining, ChinaContact: Cheng ShenNo longer taking part
  • Luoyang Central Hospital Affiliated to Zhengzhou UniversityLuoyang, ChinaContact: Xuewei ChangNo longer taking part
  • Zhongda Hospital Southeast UniversityNanjing, ChinaContact: Jiayi TongNo longer taking part
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Wenzhong ZhangNo longer taking part
  • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)Quzhou, ChinaContact: Yunkai WangNo longer taking part
  • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan UniversityShanghai, ChinaContact: Haibo LiuNo longer taking part
  • Shanghai East Hospital, Tongji University School of MedicineShanghai, ChinaContact: Wei HanNo longer taking part
  • Shanghai Putuo District Central HospitalShanghai, ChinaContact: Liu ZongjunNo longer taking part
  • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui HospitalShanghai, ChinaContact: Jing YangNo longer taking part
  • Wusong Hospital, Zhongshan Hospital, Fudan UniversityShanghai, ChinaContact: Lei ShenNo longer taking part
  • Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Aijun SunNo longer taking part
  • Shanxi Cardiovascular HospitalTaiyuan, ChinaContact: Xiurui MaNo longer taking part
  • The Second Hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Huiyu YangNo longer taking part
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Ling BaiNo longer taking part
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Junnan TangNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • placebo groupPlacebo, for comparison

    Treatment: placebo

  • Alpha-Lipoic Acid (ALA)Treatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Lipoic Acid in Chronic Ischemic Heart Failure: Assessment of Reduction in Major Adverse Cardiovascular Events
Plain-language title
Alpha-lipoic acid for long-term heart failure caused by coronary artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07725484, who can take part
Record updated
28 October 2026