Clinical trial NCT05586048: Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure
Official title: Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Heart Failure
Complementary Medicine
Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-10-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AHF in China

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AHF
* Age≥18 years
* Voluntarily participate in and sign the informed consent form

Exclusion Criteria:

* 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

Primary outcomes:
measure: 90-day all-cause mortality or readmission for HF
timeFrame: 90-day
Secondary outcomes:
measure: 180-day all-cause mortality or HF readmission
timeFrame: 180-day
measure: cardiac-specific death
timeFrame: 180 day
measure: MACE
timeFrame: 180 day
measure: length of hospital stay
timeFrame: during the hospitalization of patients, an average of 10 days
measure: dyspnoea via visual analogue scale (VAS)
timeFrame: during the hospitalization of patients, an average of 10 days
measure: dyspnoea via Likert 7-point scale
timeFrame: during the hospitalization of patients, an average of 10 days
measure: NYHA cardiac function classification
timeFrame: 180 day
measure: Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale
timeFrame: 180 day
measure: Morisky Medication Adherence Scale (MMAS)-8 scale
timeFrame: 180 day
measure: heart rate
timeFrame: 180 day
measure: number of participants eligible for the randomized controlled trial of AUGUST-AHF
timeFrame: at admission
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang
state: Guizhou
city: Guiyang
country: China
facility: The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
state: Guizhou
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Xuecheng Zhang, MD
role: STUDY_DIRECTOR
References:
citation: Zhang J, Sun Y, Zhou K, Zhang X, Chen Y, Hu J, Zhong C, Liu Y, Shang H. Rationale and design of the AUGUST-AHF Study. ESC Heart Fail. 2020 Oct;7(5):3124-3133. doi: 10.1002/ehf2.12787. Epub 2020 Jun 22.