Objectives of Study:
|
The primary objective of this study was to assess whether ShenkuiTongmai Granules were superior to a placebo for CHF treatment and to explore the mechanism of therapeutic action. And evaluate its safety by observing blood and urine routine, heart, liver and kidney function and adverse events.
|
Inclusion criteria
|
1. Voluntary participation, understanding and signing of informed consent;
2. Subject is between 18 and 75 years old, gender unlimited;
3. Subject is diagnosed of CHF for at least 3 months prior to screening according to the Chinese guidelines for the diagnosis and management of CHF published in 2018;
4. Subject has a documented left ventricular ejection fraction (LVEF) ≤ 50%;
5. NYHA heart function classification Ⅱ ~ Ⅲ Ⅳ level (hemodynamic stability, and does not need intravenous medication).
6. Plasma NT-proBNP content ≥ 450pg/ml;
7. Patients who have received at least 2 weeks of standardized drug therapy, and have not adjusted the dosage or given intravenous therapy;
Standardized drug therapy includes: diuretics, beta blockers, renin-angiotensin-aldosterone system (ACEI, ARB, and aldosterone receptor antagonists); Digitalis may be used if accompanied by atrial fibrillation.
|
Exclusion criteria:
|
1. Heart failure caused by valvular disease, congenital heart disease, pericardium disease, arrhythmia and non-cardiogenic diseases, or failure of important organs such as liver and kidney;
2. Right heart failure caused by definite pulmonary or other causes, and acute heart failure, or heart failure after acute myocardial infarction;
3. Patients who planned to undergo revascularization therapy within 12 weeks, underwent cardiac resynchronization therapy, or planned to undergo cardiac resynchronization therapy within 12 weeks;
4. Patients with severe primary diseases such as liver, kidney and hematopoietic system and abnormal renal function had liver transaminase and alkaline phosphatase exceeding 1.5 times the upper limit of normal value, serum creatinine > 2mg/ dL (176.82umol/L) and serum potassium BBB>5mmol /L;Cancer patients, severe neuroendocrine system diseases and psychiatric patients;
5. Patients with unrepaired valvular heart disease with left ventricular outflow tract obstruction, myocarditis, large aneurysm, dissecting aneurysm, congenital heart disease, or significant hemodynamic changes;
6. Cardiac shock, difficult to control the degree of malignant arrhythmia, Ⅱ Ⅱ type above not in pacemaker treatment of sinus or atrioventricular block, progression of unstable angina and acute myocardial infarction;
7. Patients with uncontrolled hypertension with systolic blood pressure ≥180/mmHg and/or diastolic blood pressure ≥110mmHg;Systolic blood pressure <90mmHg and/or diastolic blood pressure <60mmHg;
8. Participated in other drug clinical researchers within 1 month;
9. Women who are pregnant or preparing to become pregnant and breastfeeding;
10. People with allergies or known allergies to therapeutic drugs;
11. In the investigator's judgment, the patient is unable to complete the study or to comply with the study requirements (for administrative or other reasons).
|