Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure (AUGUST-AHF)

China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Complementary Medicine; Acute Heart Failure; Chinese Medicine

Treatments: Drug: Yiqi Fumai Lyophilized Injection(YQFM)

Study type: Observational

Funder types: Other

Identifiers

NCT05586048

AUGUST-AHF cohort

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

Exposed group

Description:

patients who received YQFM

Treatment:

Drug: Yiqi Fumai Lyophilized Injection(YQFM)

Non-exposed group

Description:

patients who didn't receive YQFM