Clinical trial NCT03189901: Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
Official title: Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Early Management
Acute Heart Failure
NSTEMI - Non-ST Segment Elevation MI
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood NT-proBNP Level on 3 Days after Random Allocation
timeFrame: Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.
measure: Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
timeFrame: 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:
measure: Acute Heart Failure Attack in Hospital
timeFrame: 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.
measure: Major Adverse Cardiovascular and Cerebrovascular Events in Hospital
timeFrame: 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.
measure: Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months
timeFrame: The data is collected on 6 months after patients discharged. Investigators analyse and summary the statistic difference between two groups through study completion.
measure: Security evaluation of levosimendan
timeFrame: 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.
measure: Health Economics Analysis
timeFrame: 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.
measure: Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation
timeFrame: 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.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing China-Japan Friendship Hospital
state: Beijng
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandog
city: Binzhou
country: China
facility: Binzhou People's Hospital
state: Shandong
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Tai'an
country: China
facility: Tai'an Central Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Yantai
country: China
facility: Yantaishan Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
Study officials:
References: