Auxiliary Strategy of Yiqi Fumai Lyophilized Injection on Standard Therapy in Acute Heart Failure
- Conditions
- Acute Heart Failure
- Registration Number
- ITMCTR2000002994
- Lead Sponsor
- Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Clearly diagnose patients admitted to acute heart failure;
2. Aged >= 18 years;
3. Voluntarily participate in and sign the informed consent form;
4. Randomization can be assigned within 16 hours of admission (including outpatient, ward, ICU/CCU or emergency department).
1. The duration of systolic blood pressure during the screening period was less than 90mmHg.
2. It is known that hypertension patients refuse treatment, or systolic blood pressure >= 180mmHg, diastolic blood pressure >= 110mmHg after drug treatment;
3. Before entering the group, the hematocrit is less than 25%, the hemoglobin (Hgb) is less than 8.0g / dl, or there is a history of blood transfusion within 14 days before screening, or gastrointestinal bleeding that is life-threatening actively;
4. Body temperature > 38 degree C (oral or equivalent) or sepsis or active infection requiring intravenous antimicrobial therapy;
5. Within 60 days before entering the group, major neurological events occurred, including cerebrovascular events.
6. Known liver injury or potentially severe liver disease (abnormal liver function) (ALT or AST > 3 times normal, alkaline phosphatase or bilirubin > 2 times normal);
7. Patients with known severe impairment of renal function (eGFR < 25mL/min/1.73m2), or acute contrast nephropathy planned or being dialyzed or screened;
8. At present or within 30 days before entering the group, there is clinical evidence of acute coronary syndrome. (note: the diagnosis of acute coronary syndrome is a clinical diagnosis, considering that troponin concentration may significantly increase in acute heart failure, only the increase of troponin concentration is not enough to diagnose acute coronary syndrome.).
9. Acute heart failure caused by known severe arrhythmias (including any of the following: ventricular tachycardia, bradycardia with ventricular rate < 45 beats / min, or atrial fibrillation / flutter with ventricular rate > 120 beats / min);
10. It is known to have acute myocarditis, hypertrophic obstructive, invasive or contractile cardiomyopathy (excluding the restricted mitral filling pattern shown by Doppler echocardiography), complex congenital heart disease, constrictive pericarditis or tamponade, etc. (obvious left ventricular outflow tract obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis, or aortic valve area < 1.0 cm2 or previous or current echocardiography showed mean pressure difference > 50mmhg), or severe mitral stenosis;
11. Severe aortic insufficiency or severe mitral regurgitation require surgery or percutaneous interventional therapy.
12. Dyspnea caused by non-cardiac causes, such as acute or chronic respiratory diseases or infections (i.e. severe chronic obstructive pulmonary disease, pulmonary embolism, bronchitis, pneumonia);
13. A patient who has received any organ transplant or is currently receiving an organ transplant (that is, patients who are not excluded from the waiting list for transplant);
14. Currently (including within 2 hours before screening) or planned to provide mechanical circulation support (endotracheal intubation mechanical ventilation; intra-aortic balloon pump or any ventricular assist device; hemofiltration or dialysis);
15. Used trial drugs 3 months before screening or trial, or participated in other clinical researchers within 30 days before treatment;
16. Unable to follow the doctor's advice or complete the follow-up treatment or follow-up process;
17. Pregnant or lactating women or those who are prepared to give birth within 3 months after the cessation of medication (women with reproductive potential, that is, all women who are physically able to conceive, unless they use effective contraceptive methods during the study and
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method major adverse cardiac events (MACE);90-day HF rehospitalization;90-day all-cause death;
- Secondary Outcome Measures
Name Time Method change in NYHA functional class;change in NT-proBNP;WHF through day 10;180-day HF rehospitalization;changes in Minnesota heart failure quality of life (MLHFQ) scale through day 180;length of hospital stay;Likert 7-point comparator scale;180-day all-cause death;total amount of intravenous diuretics;90-day cardiovascular death;change in dyspnea visual analogue scale (VAS) score;