Heart Failure with Reduced Ejection Fraction
Conditions
Interventions
Experimental Group:Standard treatment+Shenfu Qiangxin Pills
Control Group:Standard treatment+Placebo Pliis
Sponsors
Beijing Chaoyang Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Age: =18 years and =80 years, regardless of gender, region, or ethnicity. (2)Echocardiography: LVEF =40%. (3)Traditional Chinese Medicine (TCM) Diagnosis: Confirmed as Yang Deficiency with Blood Stasis and Fluid Retention Syndrome (4)Meet HFrEF Diagnosis with the following criteria: 1)NT-proBNP: =450 pg/mL (or =600 pg/mL for patients with atrial fibrillation). 2)NYHA Functional Class: II-III, with clinically stable symptoms. (5)Must have received standardized HFrEF drug therapy for at least 2 weeks without dosage adjustments and no intravenous medications administered in the past 2 weeks. (6)No Conflicting Herbal Usage: No concurrent use of other Chinese/herbal medicines with similar or identical ingredients to Shenfu Qiangxin Pills. (7) Willing to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Does not meet the inclusion criteria; (2) Patients with concurrent acute coronary syndrome, pulmonary embolism, or acute cerebrovascular disease; (3) Poorly controlled hypertension after treatment adjustment (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg; systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg); (4) Patients with severe hepatic or renal dysfunction: level of liver transaminases (ALT or AST) or bilirubin exceeding 3 times the upper limit of normal, glomerular filtration rate <15 mL/min/1.73 m², or those with neuroendocrine disorders or terminal-stage malignant tumors in a cachectic state affecting cardiac function; (5) Patients with active tuberculosis or autoimmune rheumatic diseases; (6) Patients with hematologic disorders, organ transplant recipients, or those with uremia; (7) Patients with uncontrolled psychiatric disorders or active drug users who have not undergone detoxification; (8) Participation in other clinical trials within one month; (9) Women who are planning for pregnancy, currently pregnant, or breastfeeding; (10) Usage of traditional Chinese herbal medicine within the past one week; (11) Patients with cardiogenic shock, refractory malignant arrhythmias, second-degree type II or higher sinoatrial or atrioventricular block without pacemaker implantation, progressive unstable angina, or acute myocardial infarction; (12) Patients with left ventricular outflow tract obstruction, myocarditis, large aortic aneurysms, aortic dissection, or uncorrected valvular heart disease causing significant hemodynamic disturbances; (13) Individuals with a history of allergies or known hypersensitivity to the study medications; (14) Patients deemed by the investigator to be unable to complete the study or comply with its requirements (due to administrative or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite cardiovascular event incidence rate(the incidence of heart failure readmission);Composite cardiovascular event incidence rate(cardiovascular mortality rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiagram;echocardiagraphy;N-terminal prohormone of brain natriuretic peptide;hepatic function;renal function; EuroQol Five Dimensional Questionnaire ;6-Minute Walk Test ;TCM Symptom Scale;Secondary composite endpoints (malignant arrhythmia, acute myocardial infarction, non-fatal stroke, etc.);Kansas City Cardiomyopathy Questionnaire (KCCQ);symptoms;signs;All-causemortality; | — |
Countries
China
Contacts
Public ContactLin Zhao
Beijing Chaoyang Hospital ,Capital Medical University
Outcome results
None listed