Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- 90-day all-cause mortality or readmission for HF
研究概览
简要总结
The goal of this cohort study is to observe the effectiveness of Yiqi Fumai Lyophilized Injection (YQFM) in patients with acute heart failure (AHF). It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but information will be collected during the hospital stay and during the follow-up period of 180 days . Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate.
详细描述
It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but patients will be asked to answer questions(such as scales or reporting of symptoms ) and provide biochemical or imaging tests, as well as undergo regular follow-up. Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate. We will also collect information on medication adherence during the follow-up period and remotely test patients during the follow-up period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AHF
- •Age≥18 years
- •Voluntarily participate in and sign the informed consent form
排除标准
- •With major psychiatric disorders or unable to complete follow-up assessment
- •Known allergies to drugs or drug ingredients
- •Patients enrolled in other trials within 1 month
研究组 & 干预措施
Exposed group
patients who received YQFM
干预措施: Yiqi Fumai Lyophilized Injection(YQFM) (Drug)
结局指标
主要结局
90-day all-cause mortality or readmission for HF
时间窗: 90-day
90-day all-cause mortality or readmission for HF
次要结局
- heart rate(180 day)
- cardiac-specific death(180 day)
- number of participants eligible for the randomized controlled trial of AUGUST-AHF(at admission)
- 180-day all-cause mortality or HF readmission(180-day)
- Morisky Medication Adherence Scale (MMAS)-8 scale(180 day)
- MACE(180 day)
- length of hospital stay(during the hospitalization of patients, an average of 10 days)
- dyspnoea via visual analogue scale (VAS)(during the hospitalization of patients, an average of 10 days)
- NYHA cardiac function classification(180 day)
- dyspnoea via Likert 7-point scale(during the hospitalization of patients, an average of 10 days)
- Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale(180 day)
研究者
Yan Liu, MD
Principal Investigator
China Academy of Chinese Medical Sciences