Rationale and design of the AUGUST‐AHF Study

ESC heart failure - Tập 7 Số 5 - Trang 3124-3133 - 2020
Jingjing Zhang1, Yang Sun2, Kehua Zhou3, Xiaoyu Zhang1, Ying Chen1, Jiayuan Hu1, Changming Zhong1, Yan Liu1, Hongcai Shang1
1Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
2Beijing University of Chinese Medicine, Beijing, China
3Catholic Health System Internal Medicine Training Program University at Buffalo Buffalo NY USA

Tóm tắt

AbstractAimsWe 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 resultsThe 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.ConclusionsTo 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.

Từ khóa


Tài liệu tham khảo

Ponikowski P, 2016, ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC, Eur J Heart Fail, 2016, 891, 10.1002/ejhf.592

10.1016/j.jacc.2017.04.025

Heart Failure Group of Chinese Society of Cardiology of Chinese Medical Association, 2018, Chinese guidelines for the diagnosis and treatment of heart failure 2018, Chinese Journal of Cardiology, 46, 760

10.1016/j.jacc.2008.10.041

10.1002/ejhf.813

10.1002/ejhf.890

10.1093/ehjcvp/pvv046

10.1016/j.jjcc.2016.02.004

10.1254/jphs.12261FP

10.1016/j.jphs.2015.02.003

10.1016/j.jep.2013.04.019

Zhang Q, 2015, Effects of YiqiFumai injection on cardiac function and heart failure markers in rats with chronic heart failure, Liaoning Journal of Traditional Chinese Medicine, 42, 2233

Zhang Q, 2016, Regulative effects of Yiqifumai injection on the activity of matrix metalloproteinase in rats with chronic heart failure, Chinese Journal of Integrative Medicine on Cardio‐/Cerebrovascular Disease, 14, 825

10.1016/j.jep.2017.02.032

National healthcare security administration.National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued a list of drugs for access to national health insurance negotiations in 2019.http://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=e7668697762148cab602a67cb820bdcb.pdf(28 November2019)

Xie N, 2019, Meta analysis on curative effects of YiqiFumai injection (lyophilization) for heart failure, Chinese Journal of Integrative Medicine on Cardio‐/Cerebrovascular Disease, 17, 1499

10.1136/bmj.332.7556.1506

10.1016/j.cardfail.2017.09.014

10.1002/ejhf.1630

Chen Q, 2019, Analysis and practice of reliability and validity evaluation of medication compliance in patients with chronic cardiovascular disease by Chinese version of MMAS‐8, China Pharmacy, 30, 268

10.1001/jama.297.12.1319

10.1001/jama.2013.1954

10.1016/S0140-6736(12)61855-8

Ju A, 2018, Pharmacological effects and clinical research progress of YiqiFumai lyophilized injection, Drug Evaluation Research, 41, 354

10.1038/nrcardio.2015.14

10.1002/ejhf.598

10.1056/NEJMoa1100171

10.1093/eurheartj/ehp458

Food S, 2013, National Drug Standards (amendment) promulgated pieces, Drug Stand China, 14, 448

10.1016/j.ejheart.2004.04.007

10.1093/eurjhf/hft095

10.1002/ejhf.516

10.1007/s10557-018-6791-0

Thông tin
Thông tin xuất bản

ESC heart failure

Tập 7 Số 5

3124-3133

Thông tin tác giả