Objective To evaluate the efficacy and safety of Shenfu Yixin Granules（ 参附益心颗粒） in the treatment of chronic heart failure（ CHF）. Methods A multicenter

randomized

double-blind

placebo-controlled approach was used. Totally 300 patients with CHF were randomized into 151 patients in the treatment group and 149 patients in the control group. On the basis of health education

the treatment group used western medicine standard treatment plus traditional Chinese medicine（ TCM） syndrome differentiation treatment

dividing syndromes of heart qi（ yang） deficiency

heart and blood stasis obstruction

heart-yang deficiency with mutual resistance of phlegm and blood stasis. And they were respectively given Shenfu Yixin Granules and modified Shenfu Yixin Granules. The control group was treated with western medicine standard treatment plus TCM simulation drugs. Both groups were treated for6 months. The ejection fraction（ EF）

TCM syndrome score

6-min walking distance（ 6 MWD）

Minnesota living with Heart Failure Questionnaire（ MLHF-Q） scores of the 2 groups were compared before and after 3

6 months treatment

and the cardiac function and TCM syndrome efficacy were evaluated. Safety evaluation was conducted.Results The total effective rate of cardiac function in the treatment group was 82. 4%

and that in the control group was 54. 26%. The treatment group was superior to the control group（ P < 0. 01）. The total effective rate of TCM syndromes in the treatment group was 93. 55%

and that in the control group was 59. 23%. The treatment group was higher than the control group（ P < 0. 01）. After treatment

EF and 6 MWD of both groups were increased and the scores of TCM syndrome and MLHF-Q were decreased（ P < 0. 01）. After 6 months of treatment

the 6 MWD of the treatment group was longer than that of the control group

and the score of TCM syndrome was lower than that of the control group（ P < 0. 01）. The difference of EF and MLHF-Q scores between groups was not statistically significant（ P > 0. 05）. There were 18 cases with adverse events in the treatment group and 16 cases in the control group.Conclusion Shenfu Yixin Granules with TCM syndrome differentiation and western medicine treatment can further improve the cardiac function of patients with chronic heart failure

improving exercise capacity

clinical symptoms and signs

and have better safety.