Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia
NCT ID: NCT06684509
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2024-11-30
2029-09-30
Brief Summary
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The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.
The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.
The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Non Atrovastatin group
control group of the same condition they will not tkae atrovastatin
No interventions assigned to this group
Atrovastatin group
patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months
Atrovastain
atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months
Interventions
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Atrovastain
atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Esraa Mahmoud Abd Rabou
Physician
Locations
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Assiut university
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Atorvaststin and cardiotoxicit
Identifier Type: -
Identifier Source: org_study_id
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