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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03189901
Other study ID # QLemer2017030
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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