Rationale and design of the AUGUST‐AHF Study

Abstract Aims We aim to assess the effect of a lyophilized herbal injection on 90 day mortality and readmission rates in patients with acute heart failure (AHF). Methods and results The AUGUST‐AHF study is a multicentre, randomized, double‐blind, placebo‐controlled trial enrolling 1270 hospitalized patients for AHF. Patients are randomized to receive YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, in addition to standard therapy, using a 1:1 ratio via an interactive web response system. The primary endpoint is the 90 day all‐cause mortality or AHF readmission rates. Secondary endpoints include 180 day all‐cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac‐specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events. Additional secondary endpoints include change in dyspnoea via visual analogue scale (VAS) and Likert 7‐point comparator scale, N terminal pro‐B‐type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization. Study recruitment is expected to be completed by March 2021, and follow‐up will end in September 2021. In an optional sub‐study, patients will be followed up for 3 years. Conclusions To our best knowledge, AUGUST‐AHF is the first study assessing the efficacy of a Chinese herbal injection in patients with AHF. The results will be valuable to guide clinicians in using YiqiFumai lyophilized injection, which was included in the latest Chinese Health Insurance Catalog.