Effect of Yiqi Fumai injection improves exercise tolerance in patients with chronic heart failure: a prospective, open-label, randomized, controlled clinical trial

BACKGROUND: Chronic heart failure (CHF) has become a significant global disease burden due to its high prevalence, re-hospitalization rate, and mortality rate. Decreased exercise tolerance is a typical manifestation of CHF patients, which severely impairs their quality of life. Yiqi Fumai injection (YQFM), an injectable drug, is a representative medication recommended by Chinese guidelines for the treatment of CHF. It has significant advantages in improving the clinical symptoms and quality of life of CHF patients. However, there is still a lack of high-quality evidence-based evidence to support clinical decisions in improving exercise tolerance. PURPOSE: The aim of this study was to evaluate the clinical effect of YQFM in improving the exercise tolerance of patients with CHF, and to promote the overall prevention and treatment level of CHF. STUDY DESIGN AND METHODS: This was a single-center, prospective, open-label, randomized, controlled clinical trial that included patients with heart failure (CHF) who had a brain natriuretic peptide (BNP) level > 35 ng/L, NYHA cardiac function classification of grades II to IV, and were aged 18 to 90 years, and were recruited at the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2024 to February 2025. The random allocation sequence was generated using the block randomization method to randomly assign the subjects to the control group (conventional Western medicine treatment) or the YQFM group (conventional Western medicine treatment + injection of Yiqi Fumai). The intervention period was 10 days, and the follow-up period was 60 days. The primary outcome measure was the metabolic equivalent (METs) predicted by the Veterans Specific Activity Questionnaire (VSAQ). Secondary outcome measures included 6-minute walk distance (6MWD), NYHA cardiac function classification, BNP level, cardiac ultrasound indicators, and the Kansas City Cardiomyopathy Patient Quality of Life Scale (KCCQ) score. Safety assessments of adverse events and laboratory indicators were conducted throughout the trial period. The outcome indicators were analyzed using the complete analysis set, following the intention-to-treat (ITT) principle. RESULTS: A total of 204 CHF patients completed this study. The intention-to-treat analysis showed that compared with the control group, the YQFM group had significantly higher METs at 10 days of treatment, 30 days of follow-up, and 60 days of follow-up (P < 0.05), and the improvement in METs at 60 days of follow-up was more significant [4.91 ± 1.02 vs 4.53 ± 0.96; Mean difference: 0.38; 95% CI: 0.11-0.65; P = 0.006]. The YQFM group also had significantly higher 6MWD at 10 days of treatment, 30 days of follow-up, and 60 days of follow-up compared with the control group (P < 0.05), and the improvement in 6MWD at 60 days of follow-up was more significant [347.0 (288.5, 403.3) vs 308.0 (278.0, 365.0); Median difference: 27.00; 95% CI: 8.00-49.00; P = 0.006]. The NYHA cardiac function classification, serum BNP concentration, LVEF, KCCQ score, etc. all showed significant improvement at 10 days of treatment, 30 days of follow-up, and 60 days of follow-up compared with the control group. In addition, no increased risk of adverse events was observed when using YQFM. CONCLUSIONS: YQFM has remarkable efficacy in enhancing the exercise tolerance and quality of life of patients with CHF, as well as improving their cardiac function. It also has good safety profiles.