Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

Recruiting

• Conditions: Chinese Medicine; Acute Heart Failure; Complementary Medicine
• Interventions: Drug: Yiqi Fumai Lyophilized Injection(YQFM)

• Registration Number: NCT05586048
• Lead Sponsor: China Academy of Chinese Medical Sciences

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

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Study Start: 2023-04-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	Yiqi Fumai Lyophilized Injection(YQFM)	patients who received YQFM

Primary Outcome Measures

Name	Time	Method
90-day all-cause mortality or readmission for HF	90-day	90-day all-cause mortality or readmission for HF

Secondary Outcome Measures

Name	Time	Method
heart rate	180 day	heart rate
cardiac-specific death	180 day	cardiac-specific death
number of participants eligible for the randomized controlled trial of AUGUST-AHF	at admission	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
180-day all-cause mortality or HF readmission	180-day	180-day all-cause mortality or HF readmission
MACE	180 day	major cardiovascular adverse event
length of hospital stay	during the hospitalization of patients, an average of 10 days	the length of patients staying in hospital
dyspnoea via visual analogue scale (VAS)	during the hospitalization of patients, an average of 10 days	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.
NYHA cardiac function classification	180 day	New York Heart Association cardiac function classification
Morisky Medication Adherence Scale (MMAS)-8 scale	180 day	MMAS-8 scores range from a maximum of 8 to a minimum of 0. Higher scores mean a better outcome
dyspnoea via Likert 7-point scale	during the hospitalization of patients, an average of 10 days	The Likert 7-point scores range from a maximum of 7 to a minimum of 1. Higher scores mean a better outcome.
Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale	180 day	Likert 7-point scores range from a maximum of 105 to a minimum of 0. Higher scores mean a worse outcome.

Trial Locations

Locations (3)

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, China