Early Management Strategies of Acute Heart Failure for Patients With NSTEMI (EMSAHF)

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 Overview

• Status: Enrolling by invitation
• Conditions: NSTEMI - Non-ST Segment Elevation MI; Acute Heart Failure; Early Management
• Intervention / Treatment: Drug: Regular management+Levosimendan

• Study Type: Interventional
• Enrollment (Anticipated): 470
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Qingdao, China, 266000
    • Qilu Hospital of Shandong University (Qingdao)
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Hospital
  • Beijng
    • Beijing, Beijng, China, 100000
      • Beijing China-Japan Friendship Hospital
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Affiliated Hospital of Xuzhou Medical University
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital affiliated to China Medical University
  • Shandog
    • Dongying, Shandog, China, 257000
      • Shengli Oilfield Central Hospital
  • Shandong
    • Binzhou, Shandong, China, 256600
      • Binzhou People's Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250012
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    • Tai'an, Shandong, China, 271000
      • Tai'an Central Hospital
    • Weifang, Shandong, China, 261000
      • WeiFang People's Hospital
    • Weihai, Shandong, China, 264200
      • Weihai Municipal Hospital
    • Yantai, Shandong, China, 264000
      • Yantaishan Hospital
    • Zibo, Shandong, China, 255000
      • Zibo central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular Management; Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.
Experimental: 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.	Drug: Regular management+Levosimendan; Patients are treated with regular management recommended in guidelines and levosimendan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Heart Failure; Non-ST Elevated Myocardial Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Simendan
• Other Study ID Numbers: QLemer2017030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No