NCT06684509

Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

Using of Atorvastatin for Anthracyclin _ Associated Cardiotoxicity in Hemetological Malignancies Patients.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	Atrovastain	atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study