Clinical Study of Lipoic Acid on Ischemic Heart Failure

NCT03491969 | Completed Phase 4 Results

• 1 other identifier: LAoIHF
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Had First Occurrence of the Composite Endpoint

  either all-cause death or heart failure (HF) hospitalization

  up to 24 months

Study Arms (2)

Alpha-Lipoic Acid(α-LA)

EXPERIMENTAL

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.

Drug: Alpha-Lipoic Acid(α-LA)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Alpha-Lipoic Acid(α-LA) DRUG

200 mg, po, tid

Alpha-Lipoic Acid(α-LA)

Placebos DRUG

200 mg, po, tid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, 200025, China

Location

Results Point of Contact

• Title: Dr. Hanchuan Chen
• Organization: Zhongshan hospital, Fudan University

chenhanchuan66@126.com

18459111985

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: January 1, 2019
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 14, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)