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This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity
The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.
They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.
Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy |
|
| Control Group | Placebo Comparator | Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40 Mg Oral Tablet | Drug | 40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cancer therapy related cardiac dysfunction among the two groups | cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups | Six months | |
| Changes in left ventricular volumes assessed by 3D echocardiography among the two groups | Six months |
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Inclusion Criteria:
Exclusion Criteria:
Female patients diagnosed with breast cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed L Mohamed, Master | Contact | +201141141677 | Doc.ahmedlotfy91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed L Mohamed, Master | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospitals | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single blind
| Placebo | Other | Placebo |
|
| Changes in left ventricular diastolic function among the two groups | Six months |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |