Clinical Study of Lipoic Acid on Ischemic Heart Failure

NCT ID: NCT03491969

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-02-01

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%).

Conditions

Ischemic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alpha-Lipoic Acid(α-LA)

Intervention Type: DRUG

200 mg, po, tid

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

200 mg, po, tid

Interventions

Alpha-Lipoic Acid(α-LA)

200 mg, po, tid

Intervention Type: DRUG

Placebos

200 mg, po, tid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Lei

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital

Shanghai, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LAoIHF

Identifier Type: -

Identifier Source: org_study_id