NCT03491969CompletedPhase 4
Clinical Study of Lipoic Acid on Ischemic Heart Failure
Source: ClinicalTrials.gov · Last updated 14 Jul 2025
Brief summary (registry, in English)
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 =\< 50%).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 2 Apr 2018
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Heart failure
- NCT number
- NCT03491969
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 300
- From 1 Jan 2019 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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 =\< 50%) 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.