drugset / Trial / NCT06684509

Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

NCT06684509

Phase 1/2 Not yet recruiting 46 enrolled Assiut University
RandomizedParallel-groupOpen-labelPrevention

Summary

The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL). 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.

Timeline

Start
2024-11
Primary completion
2027-09
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg