Rationale and design of the AUGUST-AHF Study

Area of Science:

• Cardiology
• Pharmacology
• Traditional Chinese Medicine

Background:

• Acute heart failure (AHF) presents a significant global health challenge with high mortality and readmission rates.
• Standard therapies for AHF have limitations, necessitating exploration of novel treatment strategies.
• Chinese herbal medicine, including lyophilized injections, is increasingly being investigated for cardiovascular conditions.

Purpose of the Study:

• To assess the efficacy of YiqiFumai lyophilized injection in reducing 90-day mortality and readmission rates in hospitalized patients with AHF.
• To evaluate the safety and impact of this herbal injection on various secondary clinical outcomes in AHF patients.

Main Methods:

• The AUGUST-AHF study is a multicenter, randomized, double-blind, placebo-controlled trial involving 1270 hospitalized AHF patients.
• Patients received either YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, alongside standard AHF treatment.
• Primary endpoint: 90-day all-cause mortality or AHF readmission. Secondary endpoints include longer-term outcomes, quality of life, and specific clinical markers.

Main Results:

• The study is ongoing, with recruitment completion expected by March 2021 and follow-up ending in September 2021.
• An optional sub-study will extend patient follow-up to 3 years.
• Results are pending but will provide critical data on the primary and secondary endpoints.

Conclusions:

• AUGUST-AHF is pioneering research into the efficacy of a Chinese herbal injection for acute heart failure.
• Findings are anticipated to guide clinical practice regarding the use of YiqiFumai lyophilized injection, a recognized therapy in China.
• This study holds potential to offer valuable insights into complementary and alternative medicine approaches for AHF management.