Iokfai Cheang, Wenming Yao, Yanli Zhou, Xu Zhu, Gehui Ni, Xinyi Lu, Shengen Liao, Rongrong Gao, Fang Zhou, Jiangang Shen, Alice Yeuk Lan Leung, Meng Jiang, Hong Kong, Ling Bai, Ailiman Mahemuti, Haitao Yuan, Yu-Gang Dong, Chun-Ka Wong, Qinghua Xu, Gaoxing Zhang, Jianhua Wu, Qi Lu, Junhai Zhang, Chunxi Cha, Qian Ren, Lu Fu, Bing Wang, Yongshun Xu, Houxiang Hu, Jing Dong, Zhuo Shang, Chaoping Yu, Songsen Li, Chen Yao, Lingling Gao, Haifeng Zhang, Anthony Rosenzweig, Zhenhua Jia, Xinli Li & QUEST Trial Committees and Investigators

Abstract

Previous findings have indicated the potential benefits of the Chinese traditional medicine Qiliqiangxin (QLQX) in heart failure. Here we performed a double-blind, randomized controlled trial to evaluate the efficacy and safety of QLQX in patients with heart failure and reduced ejection fraction (HFrEF). This multicenter trial, conducted in 133 hospitals in China, enrolled 3,110 patients with HFrEF with NT-proBNP levels of ≥450 pg ml−1 and left ventricular ejection fraction of ≤40%. Participants were randomized to receive either QLQX capsules or placebo (four capsules three times daily) alongside standard heart failure therapy. The trial met its primary outcome, which was a composite of hospitalization for heart failure and cardiovascular death: over a median follow-up of 18.3 months, the primary outcome occurred in 389 patients (25.02%) in the QLQX group and 467 patients (30.03%) in the placebo group (hazard ratio (HR), 0.78; 95% confidence interval (CI), 0.68−0.90; P < 0.001). In an analysis of secondary outcomes, the QLQX group showed reductions in both hospitalization for heart failure (15.63% versus 19.16%; HR, 0.76; 95% CI, 0.64−0.90; P = 0.002) and cardiovascular death (13.31% versus 15.95%; HR, 0.83; 95% CI, 0.68−0.996; P = 0.045) compared to the placebo group. All-cause mortality did not differ significantly between the two groups (HR, 0.84; 95% CI, 0.70−1.01; P = 0.058) and adverse events were also comparable between the groups. The results of this trial indicate that QLQX may improve clinical outcomes in patients with HFrEF when added to conventional therapy. ChiCTR registration: ChiCTR1900021929.