Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Qilu Hospital of Shandong University470 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

470

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (14)

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing China-Japan Friendship Hospital

Beijing, Beijng, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Shengli Oilfield Central Hospital

Dongying, Shandog, China

Binzhou People's Hospital

Binzhou, Shandong, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Tai'an Central Hospital

Tai’an, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

...and 4 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.