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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Atrovastatin group | No Intervention | control group of the same condition they will not tkae atrovastatin | |
| Atrovastatin group | Experimental | patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrovastain | Drug | atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiotoxicity | Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG | During the study period along 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiotoxicity events correlation to high risk patients | we will correlate cardiotoxicity with the factors that make those patients high risk group for cardiotoxicity | along 12 months |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa AbdRabou, Bacheolar of medicine | Contact | +201151477447 | mahmoudisraa01@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | 71515 | Egypt |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D006689 | Hodgkin Disease |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |