Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

Assiut University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Hodgkin Disease; Leukemia

Treatments: Drug: Atrovastain

Study type: Interventional

Funder types: Other

Identifiers

NCT06684509

Atorvaststin and cardiotoxicit

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age >18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%

Exclusion criteria

Cardiac dysfunction with EF < 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Non Atrovastatin group

No Intervention group

Description:

control group of the same condition they will not tkae atrovastatin

Atrovastatin group

Experimental group

Description:

patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Treatment:

Drug: Atrovastain