Clinical Study of Lipoic Acid on Ischemic Heart Failure

Phase 4

Completed

• Conditions: Ischemic Heart Failure
• Interventions: Drug: Alpha-Lipoic Acid(α-LA); Drug: Placebos

• Registration Number: NCT03491969
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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%).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-09
• Study Start: 2019-01-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Results First Submitted: 2025-06-24
• Results First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Results First Posted: 2025-07-11
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Alpha-Lipoic Acid(α-LA)	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.
Placebo	Placebos	Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had First Occurrence of the Composite Endpoint	up to 24 months	either all-cause death or heart failure (HF) hospitalization

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China