Objective:

2

To evaluate the clinical effect and safety of Xinfuli Granules (心复力颗粒

XFLG) in improving patients with heart failure (HF) of qi deficiency and blood stasis syndrome.

Methods:

2

In this single-center randomized controlled trial

HF patients were randomized (1:1) to either the XFLG group (178 cases) or the control group (178 cases). Patients in the control group received standard HF therapy. In addition

patients in the XFLG group were administered XFLG (10 g

3 times daily) for 12 weeks. The primary outcomes observed were the composite of all-cause mortality and HF-related hospitalization; and secondary outcomes included changes in left ventricular ejection fraction (LVEF)

N-terminal pro-brain natriuretic peptide (NT-pro BNP)

New York Heart Association (NYHA) functional class

Minnesota Living with Heart Failure Questionnaire (MLHFQ) score

Chinese medicine (CM) syndrome score

Patient Health Questionnaire-9 (PHQ-9)

and Generalized Anxiety Disorder-7 (GAD-7) scores.

Results:

2

After 12 weeks

the XFLG group demonstrated a significantly lower incidence of the primary endpoint compared to the control group (hazard ratio

0.566; 95% confidence interval: 0.325–0.988;

P

<

0.05). Besides

the XFLG group showed greater improvements in LVEF and NT-pro BNP reduction (

P

<

0.05 or

P

<

0.01). Compared with the control group

the total effective rate of NYHA functional class and CM syndrome was significantly higher; the MLHFQ

PHQ-9

and GAD-7 scores were significantly lower in the XFLG group (

P

<

0.05 or

P

<

0.01).

Conclusions:

2

XFLG combined with standard HF therapy significantly reduced the risk of all-cause mortality and HF-related hospitalization composite events

improved cardiac function

and quality of life

alleviated depressive and anxiety states in HF patients

with a favorable safety profile. These results support XFLG as a promising adjunctive treatment for HF with qi deficiency and blood stasis. (Registration No. ChiCTR2100049197)