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

Phase 4

• Conditions: ST Elevation Myocardial Infarction; Heart Failure
• Interventions: Other: placebo; Drug: Levosimendan

• Registration Number: NCT04970238
• Lead Sponsor: Zhijun Sun

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-07-11
• Study First Posted: 2021-07-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-20
• Study Start: 2021-10
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 1. Age ≥ 18 years old.
• 2. Acute anterior wall myocardial infarction (ECG indicates acute anterior wall, acute anterior wall myocardial infarction, acute extensive anterior wall myocardial infarction).
• 3. The onset time of chest pain was less than 12 hours, and agreed to emergency PCI treatment.
• 4. Be able to understand and sign informed consent voluntarily.

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Exclusion Criteria

• 1. Patients who cannot undergo PCI treatment after coronary angiography, or those who fail to open blood vessels, or refuse to undergo PCI treatment.
• 2. Those whose coronary angiography results indicated myocardial infarction caused by non-coronary artery disease or residual stenosis < 50% after reanalization of myocardial infarction without PCI treatment.
• 3. Patients with old anterior wall myocardial infarction.
• 4. Previous history of cardiac insufficiency.
• 5. Both anterior descending stent implantation, stent restenosis or stent thrombosis.
• 6. Symptomatic hypotension, systolic blood pressure < 90mmHg (still < 90mmHg with IABP)
• 7, body temperature > 38.5℃, or with serious infectious diseases (severe myocarditis, severe pneumonia, severe urinary tract infection, etc.).
• 8. Severe other organ diseases (renal insufficiency: EGFR < 30ml/min, severe liver insufficiency, moderate and severe anemia, malignant tumor, hematologic system diseases, etc.).
• 9. Known or suspected allergy to the active or inactive ingredients of the drug under study.
• 10. Participated in other drug clinical trials within 3 months before the trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	-
Levosimendan group	Levosimendan	-

Primary Outcome Measures

Name	Time	Method
Occurrence of heart failure	6 month	6 month of heart failure
Major Adverse Cardiovascular Events (MACE)	6 months	Mace is defined as cardiovascular death and cardiovascular related readmission
Left ventricular systolic function	72 hours	At 72 hours, left ventricular systolic function of AFI is as follows ( PSD, GLS, PSI)

Secondary Outcome Measures

Name	Time	Method
NT-ProBNP	30 days	Changes of NT-ProBNP at 72 hours and 30 days
Patient quality of life score	30 days	Seattle Angina Questionnaiire is used, The full score of five items in the scale is 100. The higher the score is, the better the condition is.

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China