Efficacy and safety of Zhen Wu Decoction against chronic heart failure A protocol of randomized, double-blinded, and controlled trial

Abstract

Introduction: Chronic heart failure (CHF) is the end stage of several cardiac diseases. 50% of patients with severe CHF would survive less than 1year, which has seriously affected patients' survival and quality of life. The current modern therapy could improve survival and quality of life. However, a larger number of patients still suffer from repeated hospitalization, unsatisfactory efficacy, and many side effects. In China, Zhen Wu Decoction (ZWD), a classic prescription recorded in Treatise on Febrile Diseases, was widely used for CHF. In this study, we try to conduct a prospective, double-blinded, randomized, controlled study to evaluate the efficacy and safety of ZWD in the treatment of CHF patients in China. Methods: Patients will be randomly divided into treatment group and control group in 1:1 ratio. Guideline directed medical therapies and ZWD will be provided for patients in treatment group, while guideline directed medical therapies and ZWD-granules simulations for control group. Left ventricular ejection fraction, left ventricular end diastolic diameter, left ventricular end systolic diameter, b-type natriuretic peptide, NT-proBNP, peak VO2, VO2 maximum, exercise time, and walking distance will be recorded. The data will be analyzed by SPSS 22.0. Conclusions: The results will evaluate the efficacy and safety of ZWD in the treatment of CHF patients.