Efficacy of alpha-lipoic acid in patients with ischemic heart failure: a randomized, double-blind, placebo-controlled study
10.12025/j.issn.1008-6358.2025.20250511
- VernacularTitle:硫辛酸在缺血性心衰患者中的应用效果：一项随机、双盲、安慰剂对照研究
- Author:
Hanchuan CHEN
1
;
Qin YU
2
;
Yamei XU
1
;
Chen LIU
3
;
Jing SUN
4
;
Jingjing ZHAO
3
;
Wenjia LI
5
;
Kai HU
1
;
Junbo GE
1
;
Aijun SUN
1
Author Information
1. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Key Laboratory of Cardiovascular Disease, National Clinical Study Center for Radiology and Therapy, Shanghai Clinical Medical Research Center for Radiology and Therapy (Interventional Therapy), Shanghai 200032, China.
2. Department of Cardiology, Affiliated Zhongshan Hospital of Dalian University, Dalian 116001, Liaoning, China.
3. Department of Cardiology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, Guangdong, China.
4. Department of Cardiology, Shanxi Cardiovascular Hospital, Taiyuan 030024, Shanxi, China.
5. Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
- Publication Type:Conferenceabstract
- Keywords:
alpha-lipoic acid;
ischemic heart failure;
left ventricular ejection fraction;
6-minutewalking distance;
prognosis
- From:
Chinese Journal of Clinical Medicine
2025;32(4):717-719
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the safety and effects of alpha-lipoic acid (ALA) in patients with ischemic heart failure (IHF). Methods A randomized, double-blind, placebo-controlled trial was designed (ClinicalTrial.gov registration number NCT03491969). From January 2019 to January 2023, 300 patients with IHF were enrolled in four medical centers in China, and were randomly assigned at a 1∶1 ratio to receive ALA (600 mg daily) or placebo on top of standard care for 24 months. The primary outcome was the composite outcome of hospitalization for heart failure (HF) or all-cause mortality events. The second outcome included non-fatal myocardial infarction (MI), non-fatal stroke, changes of left ventricular ejection fraction (LVEF) and 6-minute walking distance (6MWD) from baseline to 24 months after randomization. Results Finally, 138 patients of the ALA group and 139 patients of the placebo group attained the primary outcome. Hospitalization for HF or all-cause mortality events occurred in 32 patients (23.2%) of the ALA group and in 40 patients (28.8%) of the placebo group (HR＝0.753, 95%CI 0.473-1.198, P＝0.231; Figure 1A-1C). The absolute risk reduction (ARR) was 5.6%, the relative risk reduction (RRR) associated with ALA therapy was approximately 19.4% compared to placebo, corresponding to a number needed to treat (NNT) of 18 patients to prevent one event. In the secondary outcome analysis, the composite outcome of the major adverse cardiovascular events (MACE) including the hospitalization for HF, all-cause mortality events, non-fatal MI or non-fatal stroke occurred in 35 patients (25.4%) in the ALA group and 47 patients (33.8%) in the placebo group (HR＝0.685, 95%CI 0.442-1.062, P＝0.091; Figure 1D). Moreover, greater improvement in LVEF (β＝3.20, 95%CI 1.14-5.23, P＝0.002) and 6MWD (β＝31.7, 95%CI 8.3-54.7, P＝0.008) from baseline to 24 months after randomization were observed in the ALA group as compared to the placebo group. There were no differences in adverse events between the study groups. Conclusions These results show potential long-term beneficial effects of adding ALA to IHF patients. ALA could significantly improve LVEF and 6MWD compared to the placebo group in IHF patients.
