Acute MyocarditisPhase 3NCT06478667
The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity
A Phase 3 study testing levosemindan in people with Acute Myocarditis, run by Ain Shams University at 1 site in Egypt.
Trial summary
To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myocarditis
- What is being tested?
- levosemindan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 20 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Myocarditis
- Being tested
- levosemindan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosemindanDrug
inotropic agent
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 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 Receives: Drug: levosemindan |
| levosemindan group | Active comparator | 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. Receives: Drug: levosemindan |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Maintain systolic blood pressure with adequate organ perfusion
Measured: acute phase of myocarditis in 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start20 Dec 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MyocarditisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478667
- Sponsor's protocol ID
- Levosimendan in AlP
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06478667
- Acronym / sponsor ID
- Levosimendan in AlP
- Conditions
- Acute Myocarditis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: levosemindanwill 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 |
| levosemindan group | Active comparator | Drug: levosemindanwill 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levosemindaninotropic agent | Drug | control group, levosemindan group |
Primary outcome
systolic blood pressure
Time frame: acute phase of myocarditis in 24 hours
Maintain systolic blood pressure with adequate organ perfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levosemindan in people with Acute Myocarditis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: acute phase of myocarditis in 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.