Acute Heart Failure, Early Management, NSTEMI - Non-ST Segment Elevation MI
Conditions
Brief summary
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.
Interventions
DRUGRegular management+Levosimendan
Patients are treated with regular management recommended in guidelines and levosimendan.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with NSTEMI in outpatient service or admitted to hospital; 2. Patients with an elevated NT-proBNP level; 3. Patients sign the informed consent;
Exclusion criteria
1. Patients with hypotension(systolic pressure\<100mmHg), creatinine clearance rate\<30ml/min or be allergic to levosimendan; 2. Patients whose heart function grade of Killip are Level III\ IV; 3. Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor); 4. Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis; 5. Patients with serum potassium level\<3.5mmol/L; 6. Pregnant and lactating women; 7. Patients participating in other relevant clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood NT-proBNP Level on 3 Days after Random Allocation | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | Serious adverse reaction such as shock, malignant arrhythmia and so on. |
| 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. | To record the number of times of acute heart failure attack in hospital, then analyse the statistic difference between two groups. |
| 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. | 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). |
| 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. | To do health economics analysis using the data including inpatient days, hospitalization costs. |
| 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. | 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. |
Countries
China
Outcome results
None listed