Clinical Study of Lipoic Acid on Ischemic Heart Failure

Ischemic Heart Failure Clinical Trial

Official title:

Clinical Study of Lipoic Acid on Ischemic Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03491969
• Other study ID #: LAoIHF
• 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
• 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.

Related Conditions & MeSH terms

• Heart Failure
• Ischemia
• Ischemic Heart Failure

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