Trial Outcomes & Findings for Clinical Study of Lipoic Acid on Ischemic Heart Failure (NCT NCT03491969)

NCT ID: NCT03491969

Last Updated: 2025-07-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 300 participants
• Primary outcome timeframe: up to 24 months
• Results posted on: 2025-07-14

Participant Flow

Participant milestones

Measure	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. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid	Placebo Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid
Overall Study STARTED	150	150
Overall Study COMPLETED	138	139
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study of Lipoic Acid on Ischemic Heart Failure

Baseline characteristics by cohort

Measure	Alpha-Lipoic Acid(α-LA) n=138 Participants 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. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid	Placebo n=139 Participants Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid	Total n=277 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	65.7 years STANDARD_DEVIATION 11.6 • n=7 Participants	65.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	110 Participants n=7 Participants	218 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	138 Participants n=5 Participants	139 Participants n=7 Participants	277 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	138 participants n=5 Participants	139 participants n=7 Participants	277 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

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

Outcome measures

Measure	Alpha-Lipoic Acid(α-LA) n=138 Participants 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. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid	Placebo n=139 Participants Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid
Number of Participants That Had First Occurrence of the Composite Endpoint	32 Participants	40 Participants

Adverse Events

Alpha-Lipoic Acid(α-LA)

Serious events: 12 serious events

Other events: 31 other events

Deaths: 32 deaths

Placebo

Serious events: 14 serious events

Other events: 25 other events

Deaths: 40 deaths

Serious adverse events

Measure	Alpha-Lipoic Acid(α-LA) n=145 participants at risk 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. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid	Placebo n=144 participants at risk Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid
General disorders Death	2.1% 3/145 • 2 years	3.5% 5/144 • 2 years
Cardiac disorders Hospitalization for Worsened heart failure	2.8% 4/145 • 2 years	4.9% 7/144 • 2 years
Nervous system disorders Hospitalization for stroke	2.1% 3/145 • 2 years	0.69% 1/144 • 2 years
Injury, poisoning and procedural complications Hospitalization for fracture	0.69% 1/145 • 2 years	0.69% 1/144 • 2 years
Vascular disorders Hospitalization for arterial occlusive disease	0.69% 1/145 • 2 years	0.00% 0/144 • 2 years

Other adverse events

Measure	Alpha-Lipoic Acid(α-LA) n=145 participants at risk 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. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid	Placebo n=144 participants at risk Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/145 • 2 years	0.69% 1/144 • 2 years
Gastrointestinal disorders Gastrointestinal symptoms	6.9% 10/145 • 2 years	4.9% 7/144 • 2 years
Infections and infestations Infections	7.6% 11/145 • 2 years	8.3% 12/144 • 2 years
Renal and urinary disorders Worsened renal function	4.8% 7/145 • 2 years	2.8% 4/144 • 2 years
Nervous system disorders Dizziness	2.1% 3/145 • 2 years	0.69% 1/144 • 2 years

Additional Information

Dr. Hanchuan Chen

Zhongshan hospital, Fudan University

Phone: 18459111985

Email: chenhanchuan66@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place