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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03491969
Other study ID # LAoIHF
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received April 2, 2018
Last updated April 2, 2018
Start date May 1, 2018
Est. completion date April 30, 2022

Study information

Verified date April 2018
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date April 30, 2022
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients = 18 years of age, male or female.

- Patients with a diagnosis of AMI (>30 days) according to the global definition. ?Patients 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 a-LA.

- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).

? Symptomatic hypotension and/or a SBP < 100 mmHg.

? Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).

? Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula.

? Serum potassium > 5.2 mmol/L.

? Pregnant women or women preparing for birth.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alpha-Lipoic Acid(a-LA)
200 mg, po, tid
Placebos
200 mg, po, tid

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants that had first occurrence of the composite endpoint either cardiovascular (CV) death or heart failure (HF) hospitalization up to 24 months