Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Study Overview
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Brief Summary
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This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

Detailed Description
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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.

Official Title
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Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Conditions
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Doxorubicin Induced Cardiomyopathy

Intervention / Treatment
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* Drug: Atorvastatin 40 Mg Oral Tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines Exclusion Criteria: Patients with impaired LV systolic function (EF below 50%) Patients with severe valvular heart disease Patients previously diagnosed with coronary artery disease Patients with baseline elevated liver enzymes Patients with prior chemotherapy or radiation therapy Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy | Drug: Atorvastatin 40 Mg Oral Tablet<br>* 40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects<br>|
| Placebo Comparator: Control Group<br>Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Changes in left ventricular diastolic function among the two groups |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anthracyclines, Doxorubuicn, Cardiotoxicity