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CompletedNCT03491969Updated Jul 14, 2025Results posted

Clinical Study of Lipoic Acid on Ischemic Heart Failure

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

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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%).

02

Conditions studied

  • Ischemic Heart Failure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 =\< 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.

        • Patients must give written informed consent before any assessment is performed.

Exclusion criteria

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.

04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Care provider)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Alpha-Lipoic Acid(α-LA)

    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)

  • Placebo comparator
    Placebo

    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

Interventions

  • DrugAlpha-Lipoic Acid(α-LA)

    200 mg, po, tid

  • DrugPlacebos

    200 mg, po, tid

05

What researchers measure

Primary outcomes

  1. 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

06

Results

Posted Jul 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneAlpha-Lipoic Acid(α-LA)Placebo
Started150150
Completed138139
Not completed1211

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants That Had First Occurrence of the Composite Endpoint
ParticipantsAlpha-Lipoic Acid(α-LA)Placebo
Number of Participants That Had First Occurrence of the Composite Endpoint3240

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alpha-Lipoic Acid(α-LA)32/138 (23.2%)12/145 (8.3%)31/145 (21.4%)
Placebo40/139 (28.8%)14/144 (9.7%)25/144 (17.4%)
Most frequent serious events
Most frequent serious events
EventAlpha-Lipoic Acid(α-LA)Placebo
Hospitalization for Worsened heart failureCardiac disorders4/1457/144
DeathGeneral disorders3/1455/144
Hospitalization for strokeNervous system disorders3/1451/144
Hospitalization for fractureInjury, poisoning and procedural complications1/1451/144
Hospitalization for arterial occlusive diseaseVascular disorders1/1450/144
Most frequent other events
Most frequent other events
EventAlpha-Lipoic Acid(α-LA)Placebo
InfectionsInfections and infestations11/14512/144
Gastrointestinal symptomsGastrointestinal disorders10/1457/144
Worsened renal functionRenal and urinary disorders7/1454/144
DizzinessNervous system disorders3/1451/144
NasopharyngitisRespiratory, thoracic and mediastinal disorders0/1451/144

Baseline characteristics

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
Age, Continuous(years)Alpha-Lipoic Acid(α-LA)PlaceboTotal
Mean64.8 ± 10.765.7 ± 11.665.3 ± 11.2
Sex: Female, Male
Sex: Female, Male(Participants)Alpha-Lipoic Acid(α-LA)PlaceboTotal
Female302959
Male108110218
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Alpha-Lipoic Acid(α-LA)PlaceboTotal
American Indian or Alaska Native000
Asian138139277
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Alpha-Lipoic Acid(α-LA)PlaceboTotal
China138139277
07

Study locations

1 site
  • Zhongshan Hospital
    Shanghai, 200025, China
08

References and documents

Study documents

  • Study protocol · Jul 5, 2018
  • Statistical analysis plan · Jan 1, 2025

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03491969
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Xu Lei (Doctor, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Apr 9, 2018
Start date
Jan 1, 2019
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025
Results posted
Jul 11, 2025
Last update
Jul 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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