Observing the effectiveness of Yiqi Fumai Injection for acute heart failure
Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study
This study is testing if a new injection called Yiqi Fumai can help people with acute heart failure live longer and avoid going back to the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China Academy of Chinese Medical Sciences Academic / other |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT05586048 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the effectiveness of Yiqi Fumai Lyophilized Injection (YQFM) in patients diagnosed with acute heart failure (AHF). The study will assess the 90-day mortality and readmission rates by comparing patients who received YQFM with those who did not. Data will be collected during hospital stays and through follow-ups over a period of 180 days, including patient-reported outcomes and biochemical tests. The findings will be compared with results from the AUGUST-AHF randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with acute heart failure.
Not a fit: Patients with major psychiatric disorders, known drug allergies, or those enrolled in other trials within the last month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of YQFM in reducing mortality and readmission rates in acute heart failure patients.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating complementary medicine in heart failure management, though the specific use of YQFM is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing and 2 other locations
- Dongzhimen Hospital — Beijing, Beijing, China (Recruiting)
- The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang — Guiyang, Guizhou, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine — Guiyang, Guizhou, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yan liu, Doctor
- Email: sasliu@yeah.net
- Phone: 13811299493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.