Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

Acute Heart Failure Clinical Trial

— AUGUST-AHF  

Official title:

Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586048
• Other study ID #: AUGUST-AHF cohort
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: March 2023
• Source: China Academy of Chinese Medical Sciences
• Contact: Yan liu, Doctor
• Phone: 13811299493
• Email: sasliu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Chinese Medicine
• Complementary Medicine
• Heart Failure

Intervention

Drug:
• Yiqi Fumai Lyophilized Injection(YQFM)
No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang	Guiyang	Guizhou
China	The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine	Guiyang	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day all-cause mortality or readmission for HF	90-day all-cause mortality or readmission for HF	90-day
Secondary	180-day all-cause mortality or HF readmission	180-day all-cause mortality or HF readmission	180-day
Secondary	cardiac-specific death	cardiac-specific death	180 day
Secondary	MACE	major cardiovascular adverse event	180 day
Secondary	length of hospital stay	the length of patients staying in hospital	during the hospitalization of patients, an average of 10 days
Secondary	dyspnoea via visual analogue scale (VAS)	Dyspnea VAS scores range from a maximum of 10 to a minimum of 0. Higher scores mean a worse outcome. 10 means extreme dyspnea, and 0 means no dyspnea.	during the hospitalization of patients, an average of 10 days
Secondary	dyspnoea via Likert 7-point scale	The Likert 7-point scores range from a maximum of 7 to a minimum of 1. Higher scores mean a better outcome.	during the hospitalization of patients, an average of 10 days
Secondary	NYHA cardiac function classification	New York Heart Association cardiac function classification	180 day
Secondary	Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale	Likert 7-point scores range from a maximum of 105 to a minimum of 0. Higher scores mean a worse outcome.	180 day
Secondary	Morisky Medication Adherence Scale (MMAS)-8 scale	MMAS-8 scores range from a maximum of 8 to a minimum of 0. Higher scores mean a better outcome	180 day
Secondary	heart rate	heart rate	180 day
Secondary	number of participants eligible for the randomized controlled trial of AUGUST-AHF	Patients will complete a questionnaire with the help of researchers. This questionnaire includes the inclusion criteria for another study, the randomized controlled trial of AUGUST-AHF. After the patient has completed the questionnaire, the investigator will determine whether the patient meets the criteria based on the results	at admission