A randomized double-blind placebo-controlled clinical trial on the efficacy and safety of herbal medicine San-jia-fu-mai (SJFM) in the treatment of atrial fibrillation and heart failure with preserved ejection fraction (yin depletion syndrome)

To evaluate the safety and efficacy of San-jia-fu-mai (SJFM) in patients with heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF). 110 patients with HFpEF and AF were randomized in a double-blind, placebo-controlled trial to receive either SJFM or placebo for 12 weeks. Both groups received optimal medication therapy, including dapagliflozin. The primary endpoint was the improvement of KCCQ grade, Secondary endpoints included KCCQ score, E/e', NT-proBNP, and sRAGE, assessed at baseline and 4-week intervals for 12 weeks. After excluding 8 patients (4 in each group), 51 patients in each group (SJFM and placebo) completed the study and were included in the analysis. Both groups showed significant decreases in E/e′, NT-proBNP, and sRAGE at weeks 4, 8, and 12 compared with baseline ( P < 0.05). Both groups showed significant increases in KCCQ score at weeks 4, 8, and 12 compared with baseline ( P < 0.05). Furthermore, The SJFM group showed significantly greater decreases in NT-proBNP and sRAGE at weeks 4, 8, and 12 compared with the placebo group ( P < 0.05). Significant improvements in KCCQ and E/e′ were observed in the SJFM group at weeks 8 and 12. At week 12, the SJFM group showed a significantly greater improvement in KCCQ grade (94.12 % vs. 68.63 %; χ² = 9.14, P < 0.05). No serious adverse events were reported. SJFM demonstrated good efficacy, safety, and tolerability in patients with AF and HFpEF, suggesting its potential as a therapeutic option. The name of the trial register is “The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction”. The trial was registered at http://itmctr.ccebtcm.org.cn/ .