Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Study Overview
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Brief Summary
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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.

Official Title
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Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Conditions
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Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
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* Drug: Regular management+Levosimendan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with NSTEMI in outpatient service or admitted to hospital; Patients with an elevated NT-proBNP level; Patients sign the informed consent; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular Management<br>Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline. | |
| Experimental: Regular management+Levosimendan<br>Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan. | Drug: Regular management+Levosimendan<br>* Patients are treated with regular management recommended in guidelines and levosimendan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |