Rationale and design of the AUGUST-AHF Study
Jingjing Zhang1,2, Yang Sun1, Kehua Zhou3
1Beijing University of Chinese Medicine, Beijing, China.
Insights
This study investigates YiqiFumai lyophilized injection for acute heart failure (AHF) patients, evaluating its impact on mortality and readmission rates. Results will inform clinical use of this novel herbal therapy.
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.
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.
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