Clinical Study of Lipoic Acid on Ischemic Heart Failure

• Status: Not yet recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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 =< 45%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Thioctic Acid

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 =< 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.