Clinical Study of Lipoic Acid on Ischemic Heart Failure

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Ischemic Heart Failure

Treatments: Drug: Placebos; Drug: Alpha-Lipoic Acid(α-LA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03491969

LAoIHF

Details and patient eligibility

About

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%).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Alpha-Lipoic Acid(α-LA)

Experimental group

Description:

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.

Treatment:

Drug: Alpha-Lipoic Acid(α-LA)

Placebo

Placebo Comparator group

Description:

Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.

Treatment:

Drug: Placebos