Who is sponsoring NCT03491969?

NCT03491969 is sponsored by Shanghai Zhongshan Hospital.

What drugs are being tested in NCT03491969?

Interventions in NCT03491969: Alpha-Lipoic Acid(α-LA), Placebos.

What condition does NCT03491969 study?

NCT03491969 studies Ischemic Heart Failure.

Is NCT03491969 still recruiting?

NCT03491969 is currently completed. Last updated 14 July 2025.

Are results published for NCT03491969?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-14 · How we verify

NCT03491969

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study of Lipoic Acid on Ischemic Heart Failure

Completed Phase 4 Results posted Last updated 14 July 2025

What this trial tests

Phase 4 trial testing Alpha-Lipoic Acid(α-LA) in Ischemic Heart Failure in 300 participants. Completed in 1 February 2025.

Timeline

1 January 2019

Primary endpoint
1 February 2025

1 February 2025

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	other
Enrollment	300
Start date	1 January 2019
Primary completion	1 February 2025
Estimated completion	1 February 2025
Sites	1 location across China

Drugs / interventions tested

Alpha-Lipoic Acid(α-LA) — full drug profile →
Placebos — full drug profile →

Conditions studied

Ischemic Heart Failure — all drugs for Ischemic Heart Failure →

Sponsor

Shanghai Zhongshan Hospital

Who can join

18 and older, any sex, with Ischemic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Had First Occurrence of the Composite Endpoint Primary · up to 24 months

either all-cause death or heart failure (HF) hospitalization

Group	Value	95% CI
Alpha-Lipoic Acid(α-LA)	32
Placebo	40

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Alpha-Lipoic Acid(α-LA)

Serious: 12/145 (8%)

Deaths: 32/138

Placebo

Serious: 14/144 (10%)

Deaths: 40/139

Serious adverse events (5 terms)

Reaction	System	Alpha-Lipoic Acid(α-LA)	Placebo
Hospitalization for Worsened heart failure	Cardiac disorders	—	—
Death	General disorders	—	—
Hospitalization for stroke	Nervous system disorders	—	—
Hospitalization for fracture	Injury, poisoning and procedural complications	—	—
Hospitalization for arterial occlusive disease	Vascular disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Alpha-Lipoic Acid(α-LA)	Placebo
Infections	Infections and infestations	—	—
Gastrointestinal symptoms	Gastrointestinal disorders	—	—
Worsened renal function	Renal and urinary disorders	—	—
Dizziness	Nervous system disorders	—	—
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Hospitalization for Worsened heart failure, Death, Hospitalization for stroke, Hospitalization for fracture, Hospitalization for arterial occlusive disease.

Data from ClinicalTrials.gov NCT03491969 adverse events section.

Sponsor's own description

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%).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Redox regulation: mechanisms, biology and therapeutic targets in diseases.
Li B, Ming H, Qin S, Nice EC, et al · · 2025 · cited 104× · PMID 40050273 · DOI 10.1038/s41392-024-02095-6

Verify or expand the search:

Other recruiting trials for Ischemic Heart Failure

Currently open trials in the same condition.

NCT06258447 — CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction · NA · recruiting

Other Shanghai Zhongshan Hospital trials

Trials by the same sponsor.

NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03491969 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
Last refreshed: 14 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03491969.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing