Clinical efficacy of combined sacubitril/valsartan and the Chinese herbal preparation, Qili Qiangxin Capsules on reverse cardiac remodeling in patients with heart failure with reduced ejection fraction.

Abstract

Background: Heart failure with reduced ejection fraction (HFrEF) is mainly characterized by cardiac remodeling. Sacubitril/valsartan and Qili Qiangxin Capsules (QLQX a Chinese patent medicine, commonly used for the treatment of CHF with wide acceptance in Chinese patients), each benefit HFrEF alone, however, further high-quality clinical evidence is needed to confirm their combined effect on reversing cardiac remodeling.

Objective: To study the role of sacubitril/valsartan plus QLQX in reversing cardiac remodeling in HFrEF patients, and provide evidence for optimizing HFrEF treatment.

Methods: 124 HFrEF patients were admitted to our hospital from Feb 2023 to Apr 2025. After exclusions, 118 were analyzed and divided by treatment (per electronic records) into two groups: sacubitril/valsartan (58 cases) and sacubitril/valsartan + QLQX (combined group, 60 cases). Primary outcomes included left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular global longitudinal strain (GLS), and serum N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary outcomes included serum cardiac troponin I (cTnI), C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), clinical efficacy, 6-minute walking test (6MWT), Minnesota Living with Heart Failure Questionnaire (MLHFQ), and adverse events.

Results: The combined group showed significantly greater improvements in LVEF and absolute GLS (all P<0.001), greater reductions in LVEDD (P=0.026), LVESD (P=0.039) and NT-proBNP (P=0.020) than the monotherapy group. The combined group had greater reductions in CRP (P=0.003), TNF-α (P<0.001) and cTnI (P<0.001), a higher total clinical effective rate (P=0.008), a greater increase in 6MWT (P=0.025) and a greater decrease in MLHFQ score (P<0.001) than the monotherapy group. Adverse event incidence did not differ significantly between groups (P=0.431).

Conclusion: Sacubitril/valsartan combined with QLQX effectively improves cardiac structure and function, boosts HFrEF patients' clinical efficacy and quality of life, and is well-tolerated. It offers a reliable option for optimizing HFrEF treatment.