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NCT Number: NCT06684509

Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrovastain

Drug

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

Primary outcomes

  1. Cardiotoxicity

    Time frame: During the study period along 12 months

    Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG

Secondary outcomes

  1. Cardiotoxicity events correlation to high risk patients

    Time frame: along 12 months

    we will correlate cardiotoxicity with the factors that make those patients high risk group for cardiotoxicity

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa AbdRabou, Bacheolar of medicine

CONTACT

[email protected]

+201151477447

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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