Ischemic Heart FailurePhase 4NCT03491969
Clinical Study of Lipoic Acid on Ischemic Heart Failure
A Phase 4 study testing Alpha-Lipoic Acid(α-LA) in people with Ischemic Heart Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
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 =< 50%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Failure
- What is being tested?
- Alpha-Lipoic Acid(α-LA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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%).
- Conditions
- Ischemic Heart Failure
- Being tested
- Alpha-Lipoic Acid(α-LA), Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid(α-LA)Drug
200 mg, po, tid
PlacebosDrug
200 mg, po, tid
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Lipoic Acid(α-LA) | Experimental | 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. Receives: Drug: Alpha-Lipoic Acid(α-LA) |
| Placebo | Placebo comparator | Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had First Occurrence of the Composite Endpoint
either all-cause death or heart failure (HF) hospitalization
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jan 2019
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Lei, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491969
- Sponsor's protocol ID
- LAoIHF
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2018
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Lipoic Acid on Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT03491969
- Acronym / sponsor ID
- LAoIHF
- Conditions
- Ischemic Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-Lipoic Acid(α-LA) | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: PlacebosDouble blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients ≥ 18 years of age, male or female.
Key exclusion criteria (9 listed)
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic Acid(α-LA)200 mg, po, tid | Drug | Alpha-Lipoic Acid(α-LA) |
| Placebos200 mg, po, tid | Drug | Placebo |
Primary outcome
Number of Participants That Had First Occurrence of the Composite Endpoint
Time frame: up to 24 months
either all-cause death or heart failure (HF) hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha-Lipoic Acid(α-LA) in people with Ischemic Heart Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had First Occurrence of the Composite Endpoint (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.