Chronic heart failure
Conditions
Interventions
Experimental group and control group:Oral administration of optimized Yixin and conventional Western medical treatment.
Placebo control group:Oral placebo and conventional Western medical treatment.
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 85 years, both males and females are eligible; (2) Meet the diagnostic criteria for chronic heart failure; (3)Left Ventricular Ejection Fractions < 50%, and NYHA class II to IV; (4) Meet the diagnostic criteria for the syndrome of qi deficiency, blood stasis, and water retention in traditional Chinese medicine; (5)Provide written informed consent.
Exclusion criteria
Exclusion criteria: Any of the following conditions will result in exclusion: (1) Acute coronary syndrome, or severe cardiopulmonary dysfunction (Class IV heart failure, severe pulmonary dysfunction); (2) Acute aortic dissection, acute pulmonary embolism or pulmonary infarction, acute deep vein thrombosis of the lower extremities, or thrombus in the atrium; (3) Second-degree type II or higher sinoatrial or atrioventricular conduction block without pacemaker therapy, uncontrolled malignant arrhythmias (ventricular tachycardia, supraventricular arrhythmias affecting hemodynamics), or resting heart rate >120 beats per minute; (4) Myocarditis or severe valvular disease; (5) More than 50% stenosis or occlusion of the left main coronary artery, hypertrophic obstructive cardiomyopathy, peripheral blood oxygen saturation <85% at rest, or walking disabilities; (6) History of stroke within the past 6 months; (7) Poorly controlled hypertension (systolic blood pressure =160 mmHg and diastolic blood pressure =100 mmHg) and poorly controlled hyperglycemia (fasting blood glucose =8 mmol/L, random or postprandial 2-hour blood glucose =11.1 mmol/L); (8) Severe impairment of liver or kidney function, major systemic diseases involving the respiratory, nervous, or immune systems, malignant tumors, or severe trauma or infection; (9) Mental disorders, inability to express intentions correctly, alcoholism, or drug abuse and addiction; (10) Mental or physical disabilities that prevent adequate completion of the required activities for the trial; (11) Pregnancy, planned pregnancy, or lactation; (12) Major cranial, thoracic, or abdominal surgery within the past 4 weeks, or a tendency to bleed; (13) Participation in other clinical trials within the past 3 months or currently ongoing participation; (14) History of allergies or known hypersensitivity to components of the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| N-terminal pro-B-type natriuretic peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiogram;Minnesota Heart Failure Quality of Life Assessment;New York Heart Association (NYHA) Classification of Heart Function;Evaluation of Traditional Chinese Medicine (TCM) Syndromes and Symptom Scoring;6-minute walk distance; | — |
Countries
China
Contacts
Public ContactBai Rui Na
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed