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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure; Chinese Medicine; Complementary Medicine
• Intervention / Treatment: Drug: Yiqi Fumai Lyophilized Injection(YQFM)

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

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Yan Liu, Doctor; Email: sasliu@yeah.net
      • Contact: Xuecheng Zhang, Doctor; Email: zhangxuechengmail@163.com
  • Guizhou
    • Guiyang, Guizhou, China
      • Not yet recruiting
      • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang
      • Contact: Zhenghuan Li; Phone Number: 18185152056
    • Guiyang, Guizhou, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
      • Contact: Tao Xv; Phone Number: 15985015270

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with AHF in China

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group; patients who received YQFM	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
Non-exposed group; patients who didn't receive YQFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day all-cause mortality or readmission for HF	90-day all-cause mortality or readmission for HF	90-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
180-day all-cause mortality or HF readmission	180-day all-cause mortality or HF readmission	180-day
cardiac-specific death	cardiac-specific death	180 day
MACE	major cardiovascular adverse event	180 day
length of hospital stay	the length of patients staying in hospital	during the hospitalization of patients, an average of 10 days
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
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
NYHA cardiac function classification	New York Heart Association cardiac function classification	180 day
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
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
heart rate	heart rate	180 day
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

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: National Natural Science Foundation of China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): November 30, 2025
• Study Completion (Anticipated): November 30, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AUGUST-AHF cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No