Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Acute Heart Failure Clinical Trial

— EMSAHF  

Official title:

Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03189901
• Other study ID #: QLemer2017030
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 470
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Early Management
• Heart Failure
• Non-ST Elevated Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI

Intervention

Drug:
• Regular management+Levosimendan
Patients are treated with regular management recommended in guidelines and levosimendan.

Locations

Country	Name	City	State
China	Beijing China-Japan Friendship Hospital	Beijing	Beijng
China	Binzhou People's Hospital	Binzhou	Shandong
China	Shengli Oilfield Central Hospital	Dongying	Shandog
China	Anhui Provincial Hospital	Hefei	Anhui
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Qilu Hospital of Shandong University (Qingdao)	Qingdao
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	Tai'an Central Hospital	Tai'an	Shandong
China	Weifang People's Hospital	Weifang	Shandong
China	Weihai Municipal Hospital	Weihai	Shandong
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yantaishan Hospital	Yantai	Shandong
China	Zibo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.