Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

Phase 1

Not yet recruiting

• Conditions: Leukemia; Hodgkin Disease
• Interventions: Drug: Atrovastain

• Registration Number: NCT06684509
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-09
• Last Update Submitted: 2024-11-09
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrovastatin group	Atrovastain	patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity	During the study period along 12 months	Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG

Secondary Outcome Measures

Name	Time	Method
Cardiotoxicity events correlation to high risk patients	along 12 months	we will correlate cardiotoxicity with the factors that make those patients high risk group for cardiotoxicity

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt