Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
试验速览
- 阶段
- 4 期
- 入组人数
- 470
- 试验地点
- 14
- 主要终点
- Blood NT-proBNP Level on 3 Days after Random Allocation
研究概览
简要总结
There are always poor outcomes in patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to use levosimendan may reduces the risk of heart failure and improve the outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with NSTEMI in outpatient service or admitted to hospital;
- •Patients with an elevated NT-proBNP level;
- •Patients sign the informed consent;
排除标准
- •Patients with hypotension(systolic pressure<100mmHg), creatinine clearance rate<30ml/min or be allergic to levosimendan;
- •Patients whose heart function grade of Killip are Level III~IV;
- •Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor);
- •Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis;
- •Patients with serum potassium level<3.5mmol/L;
- •Pregnant and lactating women;
- •Patients participating in other relevant clinical studies.
研究组 & 干预措施
Regular management+Levosimendan
Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan.
干预措施: Regular management+Levosimendan (Drug)
结局指标
主要结局
Blood NT-proBNP Level on 3 Days after Random Allocation
时间窗: Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.
To test the blood NT-proBNP level in clinical labs 3 days after random allocation.
Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
时间窗: Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, and compare it with blood NT-proBNP level tested at first medical contact(baseline).
次要结局
- Acute Heart Failure Attack in Hospital(The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.)
- Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months(The data is collected on 6 months after patients discharged. Investigators analyse and summary the statistic difference between two groups through study completion.)
- Security evaluation of levosimendan(The data is collected during the time when levosimendan is used(an average of 24 hours). Investigators analyse and summary the statistic difference between two groups through study completion.)
- Major Adverse Cardiovascular and Cerebrovascular Events in Hospital(The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.)
- Health Economics Analysis(The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.)
- Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation(Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.)