Clinical Study of Lipoic Acid on Ischemic Heart Failure

Phase 4

• 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 =\< 45%).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Last Update Submitted: 2018-04-02
• Study First Posted: 2018-04-09
• Last Update Posted: 2018-04-09
• Study Start: 2018-05-01
• Primary Completion: 2021-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• 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 =< 45%) 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 cardiovascular (CV) death or heart failure (HF) hospitalization