Skip to content

Auxiliary Strategy of Yiqi Fumai Lyophilized Injection on Standard Therapy in Acute Heart Failure

Evidence-Based Optimization and Therapeutic Mechanism of Traditional Chinese Medicine in Prevention and Treatment of Coronary Heart Disease (Angina Pectoris-Myocardial Infarction-Heart Failure)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029117
Enrollment
Unknown
Registered
2020-01-14
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Interventions

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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 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 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

Design outcomes

Primary

MeasureTime frame
90-day all-cause death;90-day HF rehospitalization;major adverse cardiac events (MACE);

Secondary

MeasureTime frame
180-day all-cause death;180-day HF rehospitalization;90-day cardiovascular death;length of hospital stay;WHF through day 10;changes in Minnesota heart failure quality of life (MLHFQ) scale through day 180;change in dyspnea visual analogue scale (VAS) score;Likert 7-point comparator scale;change in NYHA functional class;total amount of intravenous diuretics;change in NT-proBNP;

Countries

China

Contacts

Public ContactShang Hongcai

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

shanghongcai@126.com+86 18202525733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026