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

NCT04970238 | Unknown Phase 4

• 1 other identifier: 2021PS522K
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction; Heart Failure

Keywords

Heart Failure; Levosimendan

Outcome Measures

Primary Outcomes (3)

• Occurrence of heart failure

  6 month of heart failure

  6 month

• Major Adverse Cardiovascular Events (MACE)

  Mace is defined as cardiovascular death and cardiovascular related readmission

  6 months

• Left ventricular systolic function

  At 72 hours, left ventricular systolic function of AFI is as follows ( PSD, GLS, PSI)

  72 hours

Secondary Outcomes (2)

• NT-ProBNP

  30 days

• Patient quality of life score

  30 days

Study Arms (2)

Levosimendan group

EXPERIMENTAL

Drug: Levosimendan

placebo group

PLACEBO COMPARATOR

Other: placebo

Interventions

Levosimendan DRUG

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.

Levosimendan group

placebo OTHER

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.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Patients who cannot undergo PCI treatment after coronary angiography, or those who fail to open blood vessels, or refuse to undergo PCI treatment.
• \. 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.
• \. Patients with old anterior wall myocardial infarction.
• \. Previous history of cardiac insufficiency.
• \. Both anterior descending stent implantation, stent restenosis or stent thrombosis.
• \. Symptomatic hypotension, systolic blood pressure \< 90mmHg (still \< 90mmHg with IABP)
• , body temperature \> 38.5℃, or with serious infectious diseases (severe myocarditis, severe pneumonia, severe urinary tract infection, etc.).
• \. Severe other organ diseases (renal insufficiency: EGFR \< 30ml/min, severe liver insufficiency, moderate and severe anemia, malignant tumor, hematologic system diseases, etc.).
• \. Known or suspected allergy to the active or inactive ingredients of the drug under study.
• \. Participated in other drug clinical trials within 3 months before the trial.

Sponsors & Collaborators

• Zhijun Sun: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the second Department of cardiovascular medicine

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 21, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CN (1)