TABLE 1.
AUGUST-AHF cohort study | AUGUST-AHF RCT study | |
Population | Inclusion criteria 1. Diagnosis of AHF 2. Age ≥ 18 years 3. Voluntarily participate in and sign the informed consent form; Exclusion criteria 1. With major psychiatric disorders or unable to complete follow-up assessment |
Key inclusion criteria 1. Diagnosis of AHF 2. Age ≥ 18 years 3. Voluntarily participate in and sign the informed consent form; 4. Randomization will have to be completed within 16 h of presentation Key exclusion criteria 1. SPB ≥ 90 mmHg prior to enrolment or patients with uncontrolled hypertension 2. Severe bleeding or coagulation disorders 3. Major neurological events 4. Known liver damage or potentially severe liver disease 5. Severe renal insufficiency or planned or under dialysis 6. AHF due to significant arrhythmias 7. Known to have acute myocarditis, obstructive hypertrophic cardiomyopathy, complex congenital heart disease, constrictive or restrictive pericarditis, cardiac tamponade, severe aortic stenosis, severe mitral stenosis, severe aortic, or mitral regurgitation 8. Dyspnoea due to obvious non-cardiac causes 9. Patients who have received any organ transplant 10. Current mechanical ventilation or circulation support 11. Pregnant or lactating women 12. with major psychiatric disorders, a history of any organ malignancy, or Yiqi Fumai lyophilized injection allergy |
Intervention/ Exposure and comparison |
Exposed group: with Yiqi Fumai lyophilized injection during the hospitalization Non-exposed group: without YiqiFumai lyophilized injection during the hospitalization |
Treatment group: Yiqi Fumai lyophilized injection + standardized western medications Control group: Placebo (5% glucose or 0.9% normal saline injection 250 mL) + standardized western medications |
Outcome | Primary outcome: 90-day all-cause mortality or HF readmission Secondary outcomes: 180-day all-cause death or HF readmission, length of hospital stay, 90-day cardiac-specific death, MACE, dyspnoea via VAS, dyspnoea via Likert 7-point scale, NYHA function class, MLHFQ scale, MMAS-8, heart rate at follow-up |
Primary outcome: 90-day all-cause mortality or HF readmission Secondary outcomes: 180-day all-cause mortality or HF readmission rate, length of hospital stay, 90-day cardiac-specific death, MACE, dyspnoea via VAS score, dyspnoea via Likert 7-point scale, NYHA functional class, WHF, MLHFQ scale, intravenous diuretics, NT-proBNP |
Follow-up | 180 days | 180 days |
Study design | Cohort study | RCT |
HF, heart failure; MACE, major cardiovascular adverse event; VAS, dyspnoea via visual analog scale; MLHFQ, minnesota living with heart failure quality of life; MMAS-8, morisky medication adherence scale; RCT, randomized controlled trial.