Hodgkin Disease, Leukemia
Conditions
Keywords
Cardiotoxicity, Atrovastatin
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.
Interventions
DRUGAtrovastain
atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiotoxicity | During the study period along 12 months | Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactEsraa AbdRabou, Bacheolar of medicine
Outcome results
None listed