ITMCTR2200006012尚未招募1 期
Clinical observation trial of Anti-heart Failure Intelligent Formula King
适应症
试验速览
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
- 年龄范围
- 30 至 85(—)
- 性别
- All
入选标准
- •1) Age: 30-85 years old, male or female.
- •2) Based on meeting the diagnostic criteria of western medicine for heart failure, left ventricular ejection fraction = 50% or NT-proBNP level = 450 ng/L.
- •3) Patients with TCM syndrome of yang deficiency and water stasis, qi deficiency and blood stasis.
- •4) Requirements for medical records: chronic heart failure caused by coronary heart disease or myocardial infarction, with clinical findings of chronic heart failure for at least 3 months (the patient is in the early stage of heart failure, and the diagnosis is preferably 3-6 months).
- •5) Participants have New York Heart Association (NYHA) functional class of II to III and have received fixed-dose optimal treatment for at least 2 weeks.
- •6) Participants are volunteered to participate in this study and sign the informed consent.
排除标准
- •1) Patients with other types of heart failure, including heart failure caused by valve disease, congenital heart disease, pericardial disease, arrhythmia or other noncardiogenic factors.
- •2) Possible coronary artery bypass surgery/cardiac resynchronization therapy within the next 4 weeks.
- •3) Uncorrected primary valvular disease, left ventricular outflow obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina or acute myocardial infarction.
- •4) Serious primary liver, kidney or blood disease or serious mental health condition or other uncontrolled systemic diseases.
- •5) Serum creatinine level >194.5µM or serum potassium level >5.5mM.
- •6) Alanine aminotransferase or alkaline phosphatase levels > 1.5 times the upper normal limit.
- •7) Uncontrolled blood pressure, systolic blood pressure = 180mm Hg or diastolic blood pressure = 110mm Hg.
- •8) Lactating or pregnant women.
- •9) Known or suspected of being allergic to the study drug.
- •10) Received another study drug within 30 days before randomization.
- •11) Unwilling or unable to provide written consent.
研究者
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