AUGUST-AHF: Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- 90-day all-cause mortality or readmission for HF [90-day]
90-day all-cause mortality or readmission for HF
Secondary Outcome Measures
- 180-day all-cause mortality or HF readmission [180-day]
180-day all-cause mortality or HF readmission
- cardiac-specific death [180 day]
cardiac-specific death
- 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.
- 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.
- NYHA cardiac function classification [180 day]
New York Heart Association cardiac function classification
- 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.
- 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
- heart rate [180 day]
heart rate
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of AHF
-
Ageā„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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dongzhimen Hospital | Beijing | Beijing | China | 100700 |
Sponsors and Collaborators
- China Academy of Chinese Medical Sciences
- National Natural Science Foundation of China
Investigators
- Study Director: Xuecheng Zhang, MD, Dongzhimen Hospital, Beijing University of Chinese Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- AUGUST-AHF cohort