The multi-center clinical study of ShenkuiTongmai Granules improving the diagnosis and treatment markers of chronic heart failure with Qi deficiency and blood stasis syndrome based on LC-MS/MS 
- Conditions
- Chronic heart failure
- Registration Number
- ITMCTR2100004675
- Lead Sponsor
- Jiangsu Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 ? ~ ? ? 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.
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, ? ? 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).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the proportion of patients in the ShenkuiTongmai Granule group relative to the placebo group demonstrating a decrease in NT-proBNP of at least 30%;the percent reduction in plasma NT-proBNP;
- Secondary Outcome Measures
Name Time Method Compound end point event rate;6MWD test results;NYHA classification;TCM symptom score;Minnesota Quality of Life Scale score;