Zhang Xuecheng, Kang Jing, Zhang Jingjing, Chen Ying, Dai Hengheng, Hu Mingzhi, Liu Yan, Shang Hongcai
Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
College of Traditional Chinese Medicine and College of Integrated Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Front Cardiovasc Med. 2023 Jan 10;9:1074406. doi: 10.3389/fcvm.2022.1074406. eCollection 2022.
The effect of Yiqi Fumai lyophilized injection (YQFM) on acute heart failure (AHF) patients has been evaluated in a large sample, randomized, controlled trial (AUGUST-AHF RCT study). However, restrictive eligibility criteria from a randomized clinical trial may raise concerns about the generalizability of the results to under-represented groups or complex patients with multimorbidity. Therefore, we intend to conduct the AUGUST-AHF cohort study which aims to assess the effectiveness of YQFM in patients with AHF in a real-world setting and compare the results with AUGUST-AHF RCT study.
This prospective, multicenter cohort study will be conducted at 50 secondary and tertiary hospitals in China and comprise 1,200 patients with AHF. The participants will be followed for up to at least 180 days. The primary outcome is a composite of 90-day all-cause mortality or readmission for heart failure. The secondary outcomes include length of hospital stay, cardiac-specific death, MACE, NYHA cardiac function classification. Cox proportional-hazards regression models will be used to estimate the association between YQFM use and the primary outcome. The primary analysis will use propensity-score matching methods to balance the differences in baseline variables between treatment cohorts.
Approval for the study has been obtained from the Ethical Committee of Dongzhimen Hospital (approval No. 2022DZMEC-327-02) and registered at ClinicalTrials.gov (NCT05586048). The study results will be published in peer-reviewed journals and presented at scientific conferences.
益气复脉冻干注射剂（YQFM）对急性心力衰竭（AHF）患者的疗效已在一项大样本、随机、对照试验（AUGUST - AHF RCT研究）中进行了评估。然而，随机临床试验中严格的纳入标准可能会引发对研究结果推广到代表性不足的群体或患有多种合并症的复杂患者的担忧。因此，我们打算开展AUGUST - AHF队列研究，旨在评估YQFM在真实世界环境中对AHF患者的有效性，并将结果与AUGUST - AHF RCT研究进行比较。
这项前瞻性、多中心队列研究将在中国的50家二级和三级医院进行，纳入1200例AHF患者。参与者将被随访至少180天。主要结局是90天全因死亡率或因心力衰竭再次入院的复合结局。次要结局包括住院时间、心源性死亡、主要不良心血管事件（MACE）、纽约心脏病协会（NYHA）心功能分级。将使用Cox比例风险回归模型来估计使用YQFM与主要结局之间的关联。主要分析将使用倾向得分匹配方法来平衡治疗队列之间基线变量的差异。
本研究已获得东直门医院伦理委员会批准（批准号：2022DZMEC - 327 - 02），并在ClinicalTrials.gov注册（NCT05586048）。研究结果将发表在同行评审期刊上，并在科学会议上展示。
