Heart Failure Due to Coronary Artery DiseasePhase 3NCT07725484
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
A Phase 3 study testing Alpha-Lipoic Acid (ALA) in people with Heart Failure Due to Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 23 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure Due to Coronary Artery Disease
- What is being tested?
- Alpha-Lipoic Acid (ALA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,188 participants
- Where
- 23 sitesChina
- Study dates
- 1 Nov 2026to 1 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Participants meeting any of the following criteria will be excluded:
- Previous cardiac resynchronization therapy (CRT);
- 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;
- 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;
- Participation in another investigational drug trial within 4 weeks prior to enrollment or ongoing receipt of any investigational treatment other than the study medication;
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- Pregnant or breastfeeding women;
- Known hypersensitivity or allergy to vitamin B preparations;
- Hemodynamic instability;
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Qin Yu, 0411-62893000, yuqin@dlu.edu.cn
The First Affiliated Hospital of Dalian Medical University
Dalian
Ying Liu, 0411-83635963, yingliu.med@gmail.com
Fujian provincial hospital
Fuzhou, Fujian, 35000
Yansong Guo, 0591-87557768, ysguo1234@126.com
Guangdong Provincial People's Hospital
Guangdong
Liwen Li, 020-83827812, gdghllw@163.com
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Chen Liu, +86-20-87755766, liuch75@mail.sysu.edu.cn
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Yan hui, 0571-87236666, michelleyan@zju.edu.cn
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Kangyu Chen, +86-551-62283114, ahslyycky@126.com
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiaoping Ji, +86-531-82169400, jxp64@163.com
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Cheng Shen, +86-537-5667777, shenc1988@mail.jnmc.edu.cn
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, 471009
Xuewei Chang, +86-379-63892222, xueway@126.com
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Jiayi Tong, +86-25-83272114, 101007925@seu.edu.cn
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Wenzhong Zhang, +86-532-96166, xxmczwz@163.com
Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)
Quzhou, Zhejiang, 324000
Yunkai Wang, +86-570-8895120, cloudopen002@126.com
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Aijun Sun, 021-64041990, sun.aijun@zs-hosipital.sh.cn
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality, 200062
Liu Zongjun, +86-21-22233222, liuzongjun1548@shutcm.edu.cn
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Wei Han, +86-21-38804518, dr.hanwei@foxmail.com
Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital
Shanghai, Shanghai Municipality, 200237
Jing Yang, +86-21-36682220, jing_yang@fudan.edu.cn
Wusong Hospital, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200940
Lei Shen, +86-21-56162417, 13818947416@163.com
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 201700
Haibo Liu, +86-21-67009999, haiboliu@fudan.edu
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Huiyu Yang, +86-351-3365400, yanghuiyu2010@126.com
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
Xiurui Ma, +86-351-5275550, 1234maer@163.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ling Bai, +86-29-85323805, bailingb21@sina.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Junnan Tang, +86-371-66913114, fcctangjn@zzu.edu.cn
About this study
Official title: 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.
Read more
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.
- Being tested
- Alpha-Lipoic Acid (ALA), placebo
- Keywords
- alpha lipoic acid, major adverse cardiovascular events, Ischemic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid (ALA)Drug
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.
placeboDrug
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Not described Receives: Drug: placebo |
| Alpha-Lipoic Acid (ALA) | Experimental | Not described Receives: Drug: Alpha-Lipoic Acid (ALA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
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.
Measured: From enrollment to the end of treatment at 24 months.
Hospitalization for Heart Failure
Unplanned admission to the hospital due to worsening heart failure symptoms that require intravenous treatment or intensified medical care during follow-up.
Measured: From enrollment to the end of treatment at 24 months.
Secondary outcomes (10)
Hospitalization for Heart Failure
Unplanned hospitalization due to worsening heart failure symptoms occurring during the follow-up period.
Measured: From enrollment to the end of treatment at 24 months.
Non-fatal Stroke
A new stroke event that does not result in death, diagnosed based on clinical symptoms and imaging findings, occurring during the follow-up period.
Measured: From enrollment to the end of treatment at 24 months.
Non-fatal Myocardial Infarction
A new myocardial infarction that does not result in death, diagnosed according to standard clinical criteria, occurring during the follow-up period.
Measured: From enrollment to the end of treatment at 24 months.
All-cause Mortality
Death from any cause occurring during the follow-up period.
Measured: From enrollment to the end of treatment at 24 months.
Change in Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular ejection fraction from baseline to 24 months after randomization, measured by echocardiography.
Measured: From enrollment to the end of treatment at 24 months.
Change in 6-Minute Walk Distance (6MWD)
Change in the distance walked during the 6-minute walk test from baseline to 24 months after randomization.
Measured: From enrollment to the end of treatment at 24 months.
Change in NT-proBNP Level
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels from baseline to 24 months after randomization.
Measured: From enrollment to the end of treatment at 24 months.
Change in Quality of Life Score (KCCQ)
Change in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 24 months after randomization.
Measured: From enrollment to the end of treatment at 24 months.
Unplanned Coronary Revascularization
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.
Measured: From enrollment to the end of treatment at 24 months.
Heart Transplantation
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.
Measured: From enrollment to the end of treatment at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Due to Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Lei, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725484
- Sponsor's protocol ID
- KY2026037
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoic Acid in Chronic Ischemic Heart Failure: Assessment of Reduction in Major Adverse Cardiovascular Events
- ClinicalTrials.gov ID
- NCT07725484
- Acronym / sponsor ID
- KY2026037
- Keywords
- alpha lipoic acid, major adverse cardiovascular events, Ischemic heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,188 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: placebo |
| Alpha-Lipoic Acid (ALA) | Experimental | Drug: Alpha-Lipoic Acid (ALA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- Previous cardiac resynchronization therapy (CRT);
- 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;
- 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;
- Participation in another investigational drug trial within 4 weeks prior to enrollment or ongoing receipt of any investigational treatment other than the study medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic Acid (ALA)After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months. | Drug | Alpha-Lipoic Acid (ALA) |
| placeboAfter enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months. | Drug | placebo group |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 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.
Hospitalization for Heart Failure
Time frame: 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.
10 secondary outcomes
Hospitalization for Heart Failure
Time frame: From enrollment to the end of treatment at 24 months.
Non-fatal Stroke
Time frame: From enrollment to the end of treatment at 24 months.
Non-fatal Myocardial Infarction
Time frame: From enrollment to the end of treatment at 24 months.
All-cause Mortality
Time frame: From enrollment to the end of treatment at 24 months.
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: From enrollment to the end of treatment at 24 months.
Change in 6-Minute Walk Distance (6MWD)
Time frame: From enrollment to the end of treatment at 24 months.
Change in NT-proBNP Level
Time frame: From enrollment to the end of treatment at 24 months.
Change in Quality of Life Score (KCCQ)
Time frame: From enrollment to the end of treatment at 24 months.
Unplanned Coronary Revascularization
Time frame: From enrollment to the end of treatment at 24 months.
Heart Transplantation
Time frame: From enrollment to the end of treatment at 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha-Lipoic Acid (ALA) in people with Heart Failure Due to Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aijun Sun (021-64041990, sun.aijun@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: From enrollment to the end of treatment at 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.