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Completed

NCT Number: NCT03491969

Clinical Study of Lipoic Acid on Ischemic Heart Failure

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%).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital

Shanghai, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Alpha-Lipoic Acid(α-LA)

Drug

200 mg, po, tid

Placebos

Drug

200 mg, po, tid

Primary outcomes

  1. Number of Participants That Had First Occurrence of the Composite Endpoint

    Time frame: up to 24 months

    either all-cause death or heart failure (HF) hospitalization

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2018
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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