Clinical Study of Lipoic Acid on Ischemic Heart Failure

• ClinicalTrials.gov Identifier: NCT03491969
• Recruitment Status: Not yet recruiting
• First Posted: April 9, 2018
• Last Update Posted: April 9, 2018
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Xu Lei, Shanghai Zhongshan Hospital

Study Description

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 =< 45%).

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Failure	Drug: Alpha-Lipoic Acid(α-LA); Drug: Placebos	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official Title: Clinical Study of Lipoic Acid on Ischemic Heart Failure
• Estimated Study Start Date: May 1, 2018
• Estimated Primary Completion Date: April 30, 2021
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Alpha-Lipoic Acid(α-LA); 200 mg, po, tid
Placebo Comparator: 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.	Drug: Placebos; 200 mg, po, tid

Outcome Measures

Primary Outcome Measures :

1. Number of participants that had first occurrence of the composite endpoint [ Time Frame: up to 24 months ]
   either cardiovascular (CV) death or heart failure (HF) hospitalization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Xu Lei, Doctor, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03491969
• Other Study ID Numbers: LAoIHF
• First Posted: April 9, 2018
• Last Update Posted: April 9, 2018
• Last Verified: April 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Ischemia; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Thioctic Acid; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients