chronic heart failure
Conditions
Interventions
treatment group:Intelligent Formula King+Basic treatment in Western medicine
control group:Placebo + basic treatment of Western medicine
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age: 30-85 years old, male or female; (2) On the basis of meeting the diagnostic criteria of Western medicine for heart failure, the left ventricular ejection fraction < 50%, and the NT-proBNP = 600 pg/mL; (3) the New York Heart Association (NYHA) has a grade II to III cardiac function and has received optimal treatment at a fixed dose guided by guidelines for at least 2 weeks; (4) Meet the TCM differentiation standards for yang deficiency and water pan and/or qi deficiency and blood stasis; (5) Chronic heart failure caused by ischemic heart disease, clinical manifestations of chronic heart failure for at least 3 months (it is recommended that patients are in the early stage of heart failure, and it is appropriate to be diagnosed for 3-6 months); (6) Patients who are being treated with traditional Chinese medicine need to stop the drug for 2 weeks; (7) Informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with heart failure caused by other causes, including heart failure caused by hypertensive heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, valvular heart disease, congenital heart disease, pericardial disease, arrhythmic cardiomyopathy or other non-cardiogenic factors; (2) Heart failure complicated by other causes, including primary valvular disease, left ventricular outflow tract obstruction, myocarditis, ventricular aneurysm, aneurysm, severe, uncontrolled arrhythmias affecting hemodynamics, atrial fibrillation, cardiogenic shock, unstable angina or acute myocardial infarction within 3 months; (3) Those with serious primary liver, kidney, blood diseases, serious mental health conditions or other uncontrolled systemic diseases; (4) Patients with malignant tumors and pulmonary artery embolism; (5) hemodynamically unstable heart failure, currently suffering from acute decompensated heart failure (symptoms and signs indicate worsening of chronic heart failure and may require intravenous therapy); (6) those who may receive coronary revascularization/cardiac resynchronization therapy in the next 12 weeks; (7) Left ventricular ejection fraction 221 µM (2.5mg/dl) or eGFR 5.5 mmol/L) and hypokalemia (blood potassium level < 3.5 mmol/L) that are still uncorrected by drug treatment; (10) bilirubin or AST or ALT values exceed 2 times the upper limit of normal; (11) Patients with poorly controlled hypertension (systolic blood pressure = 180mmHg and/or diastolic blood pressure =110mmHg), hypertension detection was determined after 3 tests on different days; (12) Patients with symptomatic hypotension with systolic blood pressure < 90mmHg and/or diastolic blood pressure <60mmHg; (13) Type I diabetes, diabetic ketosis, diabetic hyperosmolar coma; (14) Women who are preparing to become pregnant during pregnancy or within half a year, women who are breastfeeding; (15) Known or suspected hypersensitivity to known components of the test drug; (16) Mentally ill or cognitively impaired; (17) Those who suspect or confirm a history of alcohol addiction or drug abuse; (18) Those who have participated in other interventional clinical studies within 30 days before screening; (19) Those who the investigator believes are not suitable to participate in this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP;six-minute walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular ejection fraction;left ventricular end diastolic dimension;Left ventricular end-systolic volume index;Left atrial volume index;The E/e' value changes from baseline;TCM syndrome score;minnesota heart failure quality of life questionnaire;New York Heart Association (NYHA) functional classification;Left ventricular end-diastolic volume index; | — |
Countries
China
Contacts
Public ContactJie Wang
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed