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. 2023 Jan 10;9:1074406. doi: 10.3389/fcvm.2022.1074406

TABLE 1.

Comparison of AUGUST-AHF cohort study and AUGUST-AHF RCT study.

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.