Heart failure
Conditions
Interventions
Treatment group:Conventional treatment combined with Tongxinluo Capsules and Qiliqiangxin Capsules
Control group:Conventional treatment
Sponsors
Shijiazhuang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years, any gender; (2) 1) History of chronic ischemic cardiomyopathy heart failure or clinical evidence of heart failure in coronary heart disease, and NT-proBNP within 3 months: 18-49 years >450 pg/ml, 50-75 years >900 pg/ml, over 75 years >1800 pg/ml; left ventricular ejection fraction (LVEF) =50%; 2) NT-proBNP within 30 days after acute myocardial infarction: 18-49 years >450 pg/ml, 50-75 years >900 pg/ml, over 75 years >1800 pg/ml; left ventricular ejection fraction (LVEF) =50%; (3) Voluntarily participate, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Heart failure caused by valvular disease, congenital heart disease, pericardial disease, arrhythmia, and non-cardiogenic causes, or heart failure caused by dysfunction of important organs such as the kidney or liver, as well as right heart failure with a clear pulmonary or other cause; (2) Complicated by severe primary diseases of the liver, kidney, or hematopoietic system, abnormal renal function, liver transaminases or alkaline phosphatase exceeding 3 times the upper limit of normal, serum creatinine >2 mg/dl (176.82 µmol/L), serum potassium >5.5 mmol/L; tumor patients, severe neuroendocrine system diseases, and psychiatric patients; (3) Presence of left ventricular outflow tract obstruction, myocarditis, large artery aneurysm, dissection aneurysm, or uncorrected valvular heart disease causing significant hemodynamic changes; (4) Presence of uncontrolled malignant arrhythmias, second-degree type II or higher sinus node or atrioventricular conduction block not treated with pacemaker; (5) Uncontrolled hypertension or hypotension, systolic pressure =180 mmHg and/or diastolic pressure =110 mmHg; systolic pressure <90 mmHg and/or diastolic pressure <60 mmHg; (6) Participation in other drug clinical studies within 1 month; (7) Pregnant women, women planning to become pregnant, or breastfeeding women; (8) Individuals with allergic constitution or known allergy to the study medication; (9) As judged by the investigator, patients who cannot complete the study or comply with the study requirements (due to management reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of serum NT-proBNP that decreases by more than 30% relative to before treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the absolute decrease and decrease rate of serum NT-proBNP levels between the two groups relative to before treatment;Changes in ultrasound-related parameters (such as EF value, EF slope, etc.);Incidence of composite endpoint events consisting of cardiovascular death and rehospitalization for worsening heart failure;All-cause mortality; | — |
Countries
China
Contacts
Public ContactQiang Wang,Da Fu,Kan Sun,Yue Dong
Shijiazhuang Hospital of Traditional Chinese Medicine
Outcome results
None listed