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Clinical Study of Lipoic Acid on Ischemic Heart Failure | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Clinical Study of Lipoic Acid on Ischemic Heart Failure

NCT03491969•Shanghai Zhongshan Hospital

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%).

Eligibility

Age

18 - No limit years

Sex

ALL

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 =\< 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.

Locations (1)

Zhongshan Hospital

Shanghai, China

Key Dates

Start Date

January 1, 2019

Primary Completion Date

February 1, 2025

Completion Date

February 1, 2025

Last Updated

July 14, 2025

Enrollment

300

ACTUAL participants

Conditions

Ischemic Heart Failure

Interventions

Alpha-Lipoic Acid(α-LA)

DRUG

Placebos

DRUG

Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Clinical Study of Lipoic Acid on Ischemic Heart Failure

Inclusion Criteria

Exclusion Criteria

Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)

Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.