Coronary heart disease with chronic heart failure
Conditions
Interventions
The placebo group:Basic treatment + Xinyang tablet simulator
Experimental drug group:Basic treatment + Xinyang tablets
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of chronic heart failure of coronary heart disease; (2) Conforming to the TCM syndrome differentiation standard of qi and Yang deficiency blood stasis and water stagnation; (3) Left ventricular ejection fraction (modified biplanar Simpson method) =49% and NT-proBNP > 600 ng/L; (4) New York Heart Association (NYHA) class II-III; (5) Optimal guideline-directed fixed-dose therapy had been received for at least 2 weeks before randomization; (6) Chronic heart failure caused by ischemic heart disease with 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 3 to 6 months after diagnosis is appropriate); (7) Age between 30 and 80 years old (both ends included) regardless of gender; (8) Informed consent and signed written informed consent.
Exclusion criteria
Exclusion criteria: (1) Heart failure due to other causes including hypertrophic cardiomyopathy dilated cardiomyopathy congenital heart disease pericardial disease arrhythmic cardiomyopathy myocarditis or other non-cardiac factors; (2) Ventricular aneurysm aneurysm severe uncontrolled arrhythmia affecting hemodynamics (including ventricular arrhythmia atrial fibrillation etc.) cardiogenic shock pulmonary embolism acute cerebrovascular disease etc.; (3) Complicated with severe primary liver kidney or hematological diseases or other uncontrolled systemic diseases or malignant tumors; (4) Patients with unstable angina or acute myocardial infarction undergoing coronary revascularization or left ventricular remodeling surgery pacemaker implantation for cardiac resynchronization or cardiothoracic surgery within 3 months before screening; (5) Patients who may have received coronary revascularization/cardiac resynchronization therapy during the study; (6) Patients with chronic heart failure of coronary heart disease treated with traditional Chinese medicine or digitalis drugs within 2 weeks before randomization; (7) Left ventricular ejection fraction (modified biplanar Simpson method) 5.5 mmol/L) or hypokalemia (potassium level < 3.5mmol/L) that is not corrected by medical therapy; (10) Patients with glycosylated hemoglobin A1c (HbA1c) =9.0% or fasting blood glucose =13.9 mmol/L; (11) Moderate to severe anemia (Hb < 90g/L); (12) Patients with uncontrolled hypertension (systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg) were tested three times on different days. (13) Symptomatic hypotension with systolic blood pressure <80mmHg and/or diastolic blood pressure <50mmHg; (14) Patients with contraindications to 6-minute walk test or unable to complete the 6-minute walk test; (15) Patients with suspected or confirmed history of alcohol or drug abuse cognitive impairment or severe mental illness who cannot cooperate with the completion of the clinical trial; (16) Pregnant women or lactating women; (17) Allergic constitution such as allergic to two or more drugs or foods or known to be allergic to the ingredients of the drug used in the study; (18) Have participated in any clinical trial within 30 days before screening; (19) Those judged by the investigator to be unfit to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6-minute walking distance from baseline after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline on the Minnesota heart failure Quality of Life questionnaire after medication;The level of NT-proBNP decreased after treatment;Change of NYHA cardiac function grade from baseline after medication;Change of NT-proBNP level from baseline after medication;Changes of TCM syndrome score from baseline after medication;Incidence of MACE Events;Changes of echocardiography-related indicators from baseline after medication; | — |
Countries
China
Contacts
Public ContactLiu Hongxu
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed