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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Management | No Intervention | Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline. | |
| Regular management+Levosimendan | Experimental | Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular management+Levosimendan | Drug | Patients are treated with regular management recommended in guidelines and levosimendan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood NT-proBNP Level on 3 Days after Random Allocation | To test the blood NT-proBNP level in clinical labs 3 days after random allocation. | Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month. |
| Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Heart Failure Attack in Hospital | To record the number of times of acute heart failure attack in hospital, then analyse the statistic difference between two groups. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| Beijing China-Japan Friendship Hospital |
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| Major Adverse Cardiovascular and Cerebrovascular Events in Hospital | Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, acute heart failure and stroke when patients are in hospital. Then the investigators analyse the statistic difference between two groups. | 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 | Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, rehospitalization because of acute heart failure and stroke on 6 months. Then the investigators analyse the statistic difference between two groups. | 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 | Serious adverse reaction such as shock, malignant arrhythmia and so on. | 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. |
| Health Economics Analysis | To do health economics analysis using the data including inpatient days, hospitalization costs. | 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 | To test the blood NT-proBNP level in clinical labs 5 days after random allocation, then calculate the rate of patients whose plasma NT-proBNP level decreased at least 30%(compared with blood NT-proBNP level tested at first medical contact). | 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. |
| Beijing |
| Beijng |
| 100000 |
| China |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | 110000 | China |
| Shengli Oilfield Central Hospital | Dongying | Shandog | 257000 | China |
| Binzhou People's Hospital | Binzhou | Shandong | 256600 | China |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Jinan | Shandong | 250012 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Tai'an Central Hospital | Tai’an | Shandong | 271000 | China |
| Weifang People's Hospital | Weifang | Shandong | 261000 | China |
| Weihai Municipal Hospital | Weihai | Shandong | 264200 | China |
| Yantaishan Hospital | Yantai | Shandong | 264000 | China |
| Zibo Central Hospital | Zibo | Shandong | 255000 | China |
| Qilu Hospital of Shandong University (Qingdao) | Qingdao | 266000 | China |
| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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