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Clinical Study of Lipoic Acid on Ischemic Heart Failure

Primary Purpose

Ischemic Heart Failure

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Alpha-Lipoic Acid(α-LA)

Placebos

About this trial

This is an interventional other trial for Ischemic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 =< 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alpha-Lipoic Acid(α-LA)

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of participants that had first occurrence of the composite endpoint

either cardiovascular (CV) death or heart failure (HF) hospitalization

Secondary Outcome Measures

Full Information

NCT ID

NCT03491969

First Posted

April 2, 2018

Last Updated

April 2, 2018

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03491969

Brief Title

Clinical Study of Lipoic Acid on Ischemic Heart Failure

Official Title

Clinical Study of Lipoic Acid on Ischemic Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Anticipated)

Primary Completion Date

April 30, 2021 (Anticipated)

Study Completion Date

April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Failure

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alpha-Lipoic Acid(α-LA)

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Alpha-Lipoic Acid(α-LA)

Intervention Description

200 mg, po, tid

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

200 mg, po, tid

Primary Outcome Measure Information:

Title

Number of participants that had first occurrence of the composite endpoint

Description

either cardiovascular (CV) death or heart failure (HF) hospitalization

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 =< 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.

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Lipoic Acid on Ischemic Heart Failure

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