New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Study Overview
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Brief Summary
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Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. The complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. The project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

Detailed Description
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The most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. The aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Official Title
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New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Conditions
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Cardiotoxicity, Chemotherapy Effect, Chemotherapy Induced Systolic Dysfunction

Intervention / Treatment
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* Diagnostic Test: Blood sampling
* Diagnostic Test: Echocardiography
* Diagnostic Test: Cardio MRI
* Diagnostic Test: 24-hours monitoring of ECG
* Diagnostic Test: 24 hours monitoring of BP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer Chemotherapy with a known cardiotoxic side effect Exclusion Criteria: Known cardiovascular disease

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity<br> | Diagnostic Test: Blood sampling<br>* Blood sample collection for mRNA determination<br>Diagnostic Test: Echocardiography<br>* Echocardiography for detection of ventricular dysfunction<br>Diagnostic Test: 24-hours monitoring of ECG<br>* Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity<br>|
| Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity<br> | Diagnostic Test: Blood sampling<br>* Blood sample collection for mRNA determination<br>Diagnostic Test: Echocardiography<br>* Echocardiography for detection of ventricular dysfunction<br>Diagnostic Test: Cardio MRI<br>* MRI for early detection of myocardial impairment caused by chemotherapy<br>Diagnostic Test: 24-hours monitoring of ECG<br>* Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity<br>Diagnostic Test: 24 hours monitoring of BP<br>* Diagnostic test for detection of hypertension as a consequence of cardiotoxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early detection of the cardiotoxic effect of chemotherapy using new biomarkers | Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension | one year follow-up. |