The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity

The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity: A Randomized Controlled Trial

To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Study Overview

• Status: Completed
• Conditions: Acute Myocarditis
• Intervention / Treatment: Drug: levosemindan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Poison Control Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

• Pregnant patients
• The presence of pre-existing diseases such as hematologic, pulmonary, hepatic, renal, immunologic, central nervous system, or endocrine system disorders that made patients unsuitable for the present study.
• Patients with underlying cardiac disease and ECG changes, especially prolonged QTc intervals.
• Patients co-ingested drugs or toxins with cardiovascular toxicity.
• Patients had been previously administered with inotropic agent other than agents under the current study as a preconsultation treatment.
• Patients had received any other investigational medicinal products within 30 days or were enrolled in any other interventional trials with the potential to interact with Levosimendan or affect ALP induced cardiotoxicity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; 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; inotropic agent; Other Names: dobutamine
Active Comparator: levosemindan group; 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; Other Names: dobutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure	Maintain systolic blood pressure with adequate organ perfusion	acute phase of myocarditis in 24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Heart Diseases; Chemically-Induced Disorders; Cardiomyopathies; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Myocarditis; Cardiotoxicity; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: Levosimendan in AlP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No