Phase 4
N=300
Clinical Study of Lipoic Acid on Ischemic Heart Failure
Ischemic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03491969 ↗Enrolled (actual)
300
Serious AEs
9.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants That Had First Occurrence of the Composite Endpoint — 32; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alpha-Lipoic Acid(α-LA) (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shanghai Zhongshan Hospital
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Had First Occurrence of the Composite Endpoint |
32; 40 | — |
Summary
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%).
Eligibility Criteria
Inclusion Criteria
- 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 = 5.2 mmol/L.
⑨ Pregnant women or women preparing for birth.
Data sourced from ClinicalTrials.gov (NCT03491969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.