A Phase 3 interventional study of levosemindan in Acute Myocarditis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Ain Shams University · Phase 3, Interventional, and Supportive care
To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity
Aluminum phosphide (ALP) is a well-known fumigant known also as rice pill or wheat pill. It is considered an ideal pesticide since it is effective to preserve stored grains against insects and rodents without leaving residues, in addition to its availability and low cost. In Egypt, it has become a common method of suicide over the last few years because it is cheap and easily accessible. Cardiomyocytes are one of the main targets for ALP. ALP-induced cardiotoxicity involves detrimental effects such as direct myocardial tissue damage, hypoperfusion, myocarditis, pericarditis, and arrhythmias leading to circulatory failure. Levosimendan, an inotropic agent, enhances cardiac contractility through calcium sensitization with minimal oxygen demand and, in turn, decreases the risk of arrhythmia. However, limited studies have investigated the role of levosimendan in the treatment of ALP induced cardiotoxicity.
264 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.
This study's enrollment of 50 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
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Patients with acute ALP intoxication admitted to ICU of PCC-ASUH and developed cardiotoxicity with Poisoning Severity Score (PSS) 2 (moderate) or 3 (severe) that led to cardiogenic shock and necessitated administration of vasoactive medications
Exclusion Criteria:
will receive the traditional supportive treatment according to (PCC-ASUH) protocol • Interventions: Inotropic agent: Dobutamine Vasopressor: norepinephrine N-acetylcysteine: antioxidant Magnesium Sulphate: antiarrhythmic Sodium Bicarbonate Powder and ondansetron hydrocortisone 100 mg every 4-6h
Drug: levosemindan
will receive the traditional supportive treatment without dobutamine as inotropic agent instead levosimendan will be started in bolus dose of 6-12 µg/kg over 10 minutes followed by infusion of 0.05 - 0.2µg/kg/min with adjusting infusion rate according to response and adverse events.
Drug: levosemindan
inotropic agent
systolic blood pressure
Maintain systolic blood pressure with adequate organ perfusion
Time frame: acute phase of myocarditis in 24 hours
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University