Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acute Heart Failure, Complementary Medicine, Chinese Medicine

Intervention / Treatment
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* Drug: Yiqi Fumai Lyophilized Injection(YQFM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group<br>patients who received YQFM | Drug: Yiqi Fumai Lyophilized Injection(YQFM)<br>* No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM<br>|
| Non-exposed group<br>patients who didn't receive YQFM | |

What is the study measuring?
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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 |