Heart failure
Conditions
Interventions
Experimental group:standard treatment+Xinli Granule
Control group:standard treatment+Xinli Granule placebo
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age of 18-80 years old both sexes; (2) patients with a history of chronic heart failure for more than 3 months or clinical symptoms of heart failure for more than 3 months meeting the diagnostic criteria for chronic heart failure (according to the Chinese Guidelines for the Diagnosis and treatment of Heart Failure 2024 issued by the Chinese Society of Cardiology of the Chinese Medical Association and referring to the guidelines for heart failure related to the American Heart Association and the European Heart Association); (3) Conforming to the dialectics criteria of TCM chronic heart failure syndrome of qi deficiency and blood stasis combined with phlegm stagnation; (4) NYHA class II-III; (5) Plasma NT-pro BNP level = 450pg/ml; (6) left ventricular ejection fraction (LVEF) < 50% (modified Simpson method); (7) patients who had received guideline-recommended standard drug therapy for at least 2 weeks without dose adjustment or intravenous therapy; Standard medical therapy includes: "Angiotensin-converting enzyme inhibitors (ACEI) or angiotensin-receptor antagonists (ARB) or angiotensin-receptor neprilysin inhibitors (ARNI) beta-blockers aldosterone receptor antagonists SGLT2i soluble guanylate cyclase agonists etc. (optimal therapeutic doses should be achieved unless contraindicated or not tolerated)." (Chinese Guidelines for the diagnosis and treatment of heart failure 2024); (8) had not used or stopped using Chinese medicine or patent Chinese medicine for cardiovascular diseases at the time of enrollment; (9) Voluntary participation understanding and signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) acute heart failure or acute exacerbation of chronic heart failure; (2) heart failure due to severe congenital heart disease pericardial disease arrhythmia infective endocarditis non-cardiac causes or failure of important organs such as liver and kidney; Right heart failure with definite pulmonary or other causes; (3) combined with liver kidney hematopoietic system and other serious primary diseases abnormal renal function serum creatinine > 2mg/dl(176.82umol/L) serum potassium > 5.5mmol/L; Liver transaminase and alkaline phosphatase were 3 times higher than the upper limit of normal; Patients with cancer patients with severe neuroendocrine diseases and psychiatric disorders and patients with progressive malignant diseases whose expected survival time is less than 1 year; (4) unrepaired valvular heart disease with left ventricular outflow tract obstruction myocarditis large aneurysm dissecting aneurysm and significant hemodynamic changes; Patients with cardiogenic shock uncontrollable malignant arrhythmia sinoatrial or atrioventricular block of grade II or above without pacemaker implantation progressively aggravated unstable angina or acute myocardial infarction; (5) patients who planned to undergo coronary revascularization or cardiac resynchronization therapy in the near future and patients who had cardiac resynchronization therapy; (6) uncontrolled hypertension with systolic blood pressure =180 mmHg and/or diastolic blood pressure =110mmHg; Systolic blood pressure <80mmHg and/or diastolic blood pressure <50mmHg; Glycosylated hemoglobin A1c (HBA1c) =9.0% or fasting blood glucose =13.9mmol/L; (7) patients with allergic constitution or known to be allergic to treatment drugs; (8) participate in other drug clinical investigators within 1 month; (9) pregnant or lactating women; (10) Patients did not meet the inclusion criteria refused to sign the informed consent or were judged by the investigator to be unable to complete the study or comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of decrease in plasma NT-pro BNP of more than 30%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac Function Classification (NYHA);Echocardiography indicators;Six Minute Walk Test (6MWT);Minnesota Quality of Life Scale score (MLHFQ);Plasma NT-pro BNP levels;composite endpoint;Chinese Medicine Criteria Score; | — |
Countries
China
Contacts
Public ContactLv Weihui
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed