ITMCTR2200005839
Not yet recruiting
未知
chronic heart failure
Jiangsu Province Hospital of Integration of Chinese and Western Medicine0 sitesTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Jiangsu Province Hospital of Integration of Chinese and Western Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) It is consistent with the diagnosis of chronic heart failure in western medicine, and the history of chronic heart failure or clinical symptoms of heart failure have been found for more than 3 months;
- •(2\) The cardiac function was classified as grade II \~ IV (NYHA), and chronic heart failure was in stages C and D;
- •(3\) The syndrome differentiation of traditional Chinese medicine is Qi and yin deficiency and internal stagnation of water and blood stasis;
- •(4\) Plasma NT proBNP was greater than 600 pg / ml, and plasma NT proBNP was greater than 900 pg / ml in heart failure complicated with atrial fibrillation or atrial flutter;
- •(5\) Those who have received the optimal drug treatment of fixed dose western medicine for at least 2 weeks and have not been given intravenous therapy with vasoactive drugs or diuretics;
- •(6\) Age 18\-85 years old, regardless of gender;
- •(7\) No traditional Chinese medicine for the treatment of heart failure was used within 2 weeks before enrollment;
- •(8\) Those who voluntarily sign the informed consent form.
- •Note: after the 2\-week induction period, it is necessary to be selected again according to the above criteria and randomly included.
Exclusion Criteria
- •(1\) Acute cardiac insufficiency;
- •(2\) Coronary revascularization and cardiac resynchronization therapy within 12 weeks, or cardiac resynchronization therapy planned within 12 weeks;
- •(3\) Patients with cardiac shock, or fatal arrhythmia, sinus or atrioventricular block without pacemaker treatment above grade II, obstructive cardiomyopathy, restrictive cardiomyopathy, pulmonary heart disease, congenital heart disease, obvious hemodynamic changes, unrepaired heart valve disease, large aneurysm, dissecting aneurysm, constrictive pericarditis, myocarditis Patients with pericardial tamponade, pulmonary embolism, progressive unstable angina pectoris or acute myocardial infarction, and other diseases that affect the efficacy and safety of drugs for heart failure;
- •(4\) Combined with severe lung, liver and kidney dysfunction, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and blood creatinine exceeded the upper limit of normal value by 2 times, and blood potassium was more than 5\.5mmol/l; Serious primary diseases such as endocrine system and hematopoietic system;
- •(5\) In patients with uncontrolled hypertension, systolic blood pressure \= 180 / mmHg and / or diastolic blood pressure \= 110mmhg; Systolic blood pressure \< 90 mmHg and / or diastolic blood pressure \< 60 mmHg;
- •(6\) Pregnant or lactating women;
- •(7\) Cancer patients, with mental illness, or unwilling to cooperate;
- •(8\) Those who have participated in clinical research of other drugs within 1 month;
- •(9\) The researcher believes that it is not suitable to participate in the study.
- •Note: This study is excluded if any of the above conditions are met.
Outcomes
Primary Outcomes
Not specified
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