A Phase 4 interventional study of Alpha-Lipoic Acid(α-LA) and Placebos in Ischemic Heart Failure, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Other
The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =\< 50%).
patients ≥ 18 years of age, male or female.
Patients with a diagnosis of AMI (>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =\< 50%) and elevated BNP(NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).
Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.
Exclusion Criteria:
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
allergy to any of the study drugs, drugs of similar chemical classes(Vitamin B) as well as known or suspected contraindications to the study drugs.
Previous history of intolerance to recommended target doses of α-LA.
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
⑤ Symptomatic hypotension and/or a SBP \< 100 mmHg.
⑥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).
⑦ Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula.
⑧ Serum potassium > 5.2 mmol/L.
⑨ Pregnant women or women preparing for birth.
Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.
Drug: Alpha-Lipoic Acid(α-LA)
Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.
Drug: Placebos
200 mg, po, tid
200 mg, po, tid
Number of Participants That Had First Occurrence of the Composite Endpoint
either all-cause death or heart failure (HF) hospitalization
Time frame: up to 24 months
| Milestone | Alpha-Lipoic Acid(α-LA) | Placebo |
|---|---|---|
| Started | 150 | 150 |
| Completed | 138 | 139 |
| Not completed | 12 | 11 |
either all-cause death or heart failure (HF) hospitalization
| Participants | Alpha-Lipoic Acid(α-LA) | Placebo |
|---|---|---|
| Number of Participants That Had First Occurrence of the Composite Endpoint | 32 | 40 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alpha-Lipoic Acid(α-LA) | 32/138 (23.2%) | 12/145 (8.3%) | 31/145 (21.4%) |
| Placebo | 40/139 (28.8%) | 14/144 (9.7%) | 25/144 (17.4%) |
| Event | Alpha-Lipoic Acid(α-LA) | Placebo |
|---|---|---|
| Hospitalization for Worsened heart failureCardiac disorders | 4/145 | 7/144 |
| DeathGeneral disorders | 3/145 | 5/144 |
| Hospitalization for strokeNervous system disorders | 3/145 | 1/144 |
| Hospitalization for fractureInjury, poisoning and procedural complications | 1/145 | 1/144 |
| Hospitalization for arterial occlusive diseaseVascular disorders | 1/145 | 0/144 |
| Event | Alpha-Lipoic Acid(α-LA) | Placebo |
|---|---|---|
| InfectionsInfections and infestations | 11/145 | 12/144 |
| Gastrointestinal symptomsGastrointestinal disorders | 10/145 | 7/144 |
| Worsened renal functionRenal and urinary disorders | 7/145 | 4/144 |
| DizzinessNervous system disorders | 3/145 | 1/144 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 0/145 | 1/144 |
The primary efficacy endpoints were analyzed using the full analysis set (FAS), which followed the Intent-to-Treat (ITT) principle. Inclusion in the FAS required that participants receive the investigational drug for a minimum of 1 month. 300 patients were randomized in a 1:1 ratio to receive either ALA or a matching placebo. In the ALA group, 12 patients were excluded from the primary analysis. In the placebo group, 11 participants were excluded.
| Age, Continuous(years) | Alpha-Lipoic Acid(α-LA) | Placebo | Total |
|---|---|---|---|
| Mean | 64.8 ± 10.7 | 65.7 ± 11.6 | 65.3 ± 11.2 |
| Sex: Female, Male(Participants) | Alpha-Lipoic Acid(α-LA) | Placebo | Total |
|---|---|---|---|
| Female | 30 | 29 | 59 |
| Male | 108 | 110 | 218 |
| Race (NIH/OMB)(Participants) | Alpha-Lipoic Acid(α-LA) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 138 | 139 | 277 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Alpha-Lipoic Acid(α-LA) | Placebo | Total |
|---|---|---|---|
| China | 138 | 139 | 277 |
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Shanghai Zhongshan Hospital