NCT04970238

Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction

Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction-- Multicenter Prospective Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Zhijun Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research. Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure. The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.

Conditions

• ST Elevation Myocardial Infarction
• Heart Failure

Interventions

Type	Name	Description
DRUG	Levosimendan	Test drug: drug preparation method: 5ml (12.5mg) levosimendan injection was mixed with 500ml 5% glucose injection, the initial loading dose was 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg/ kg / min for 24 hours.
OTHER	placebo	Control drug: 5% glucose injection, intravenous injection method is the same as the experimental group pump dose, the initial load dose of treatment is 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg / kg / min for 24 hours.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-07-21
• Last updated: 2021-08-20

Locations

1 site across 1 country: China