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Clinical Study of Lipoic Acid on Ischemic Heart Failure

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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

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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