ITMCTR2200005855尚未招募1 期
Efficacy and safety of Xin-Li-Fang in the treatment of chronic heart failure:A Randomized, double-blind, placebo-controlled study
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine(Guangdong Provincial of Chinese Medicine)0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •(1)Age is above 18 years, not restrictions on male or female;
- •(2)Patients who meet the chronic heart failure diagnosis creteria, and have a history of chronic heart failure for more than 3 months, or clinical symptoms of heart failure for more than 3 months; The diagnosis of chronic heart failure was based on the 2018 Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in China;
- •(3)The syndrome differentiation of traditional Chinese medicine is the syndrome of water stopping, Qi deficiency and blood stasis;
- •(4)NYHA classification stage II-IV;
- •(5)Serum NT-proBNP>=450pg/ml;
- •(6)Patients have received standard medical treatment for more than 2 wks and no modification of dosage or intravenous administration has been given;
- •(7) To be able to and willing to provide signed informed consent.
排除标准
- •(1)CHF is caused by following condition: valvular disease, congenital heart disease, pericardial disease, cardiac arrhythmia, or other non-cardiogenic factors, including dysfunction of kidney, liver and lung;
- •(2)Patients with severe liver, kidney, hematological disease or abnormal renal or hepatic funtion (ALT and ALP > 3 UNL, Cr> 2mg/dl(176.82umol/L), serum potassium >5.5 mmol/L. Patients with tumor, severe neural, endocrine or psychological disease; The investigator judges that the survival period does not exceed 1 year;
- •(3)Combined with left ventricular outflow tract obstruction, myocarditis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, aortic aneurysm, aortic dissection, congenital heart disease, and significant hemodynamic changes in patients with silent valvular heart disease; Patients with cardiogenic shock, uncontrollable malignant arrhythmia, sinus or atrioventricular block without pacemaker treatment, progressive unstable angina pectoris or acute myocardial infarction;
- •(4)Patients undergoing cardiac resynchronization therapy, or who will undergoing coronary revascularization or cardiac resynchronization therapy within 12 weeks;
- •(5)The patients with hypertension without control, SBP=180mmHg and/or DBP=110mmHg; SBP<90mmHg and/or DBP<60mmHg;
- •(6)People with allergies, or those who are known to be allergic to this medicine and its ingredients;
- •(7)Involved in any clinical trial in recent 1 month;
- •(8)During pregnancy and lactation women;
- •(9)The investigator judged that he could not complete the study or could not comply with the requirements of the study.
研究者
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