Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Phase 4

• Conditions: NSTEMI - Non-ST Segment Elevation MI; Early Management; Acute Heart Failure
• Interventions: Drug: Regular management+Levosimendan

• Registration Number: NCT03189901
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-16
• Study Start: 2017-07-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 470

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular management+Levosimendan	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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).

Trial Locations

Locations (14)

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Binzhou People's Hospital; 🇨🇳 Binzhou, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Yantaishan Hospital; 🇨🇳 Yantai, Shandong, China

Zibo Central Hospital; 🇨🇳 Zibo, Shandong, China

Qilu Hospital of Shandong University (Qingdao); 🇨🇳 Qingdao, China

Beijing China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijng, China

Shengli Oilfield Central Hospital; 🇨🇳 Dongying, Shandog, China

Shengjing Hospital Affiliated to China Medical University; 🇨🇳 Shenyang, Liaoning, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China

Tai'an Central Hospital; 🇨🇳 Tai'an, Shandong, China

Weifang People's Hospital; 🇨🇳 Weifang, Shandong, China

Weihai Municipal Hospital; 🇨🇳 Weihai, Shandong, China