Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry

Study Overview
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Brief Summary
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The study is multicenter, post-authorization, observational and ambispective

Detailed Description
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Cardiovascular toxicity produced by antitumoral drugs has a considerable impact in life wellness and prognosis of cancer patients, which can imply the suspension of the desired antitumoral treatment or even risk the patient´s life. The development of a risk score for these patients, as well as specific methodology for early detection of cardiotoxicity would therefore be a great outcome to trigger new strategies for the monitoring of these patients. Currently there is a lack of a clinical score to predict cardiotoxicity risk. Therefore, there is an urgent need to identify new myocardial injury biomarkers and novel imaging parameters for measuring ventricular function that would increase the sensitivity of the traditional methods used for the early detection of cardiotoxicity. The objectives of the present study are the following: Identify the factors related with cardiotoxicity risk produced by antitumoral drugs. Assess the utility of clinical, biological and functional parameters for the early detection of cardiotoxicity produced by antitumoral drugs. The study is a multicenter one, observational and ambispective. We will include all the patients assessed by the Oncology and Haematology Departments in each participant hospital that are about to initiate or are undergoing chemotherapy with any of the drugs specified in the study protocol. Patients will be monitorized during the treatment, undergoing an echocardiography study and a blood sample collection in each clinical timepoint. All these parameters will hopefully shed some light for the development of a clinical risk score as well as identifying new early biomarkers for cardiotoxicity. The initial follow-up in this phase of the study will be 2 years

Official Title
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Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry

Conditions
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Cardiovascular Toxicity Induced by Antitumoral Drugs

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients> 18 years with indicated antitumor chemotherapy. Estimated survival ≥ 6 months No oxygen dependence No contraindication for taking the study target antitumor agents. No exclusion of patients with risk factors or previous heart disease. No exclusion of patients with previous cancer, previous antitumor treatment, current antitumor treatment, previous or current radiotherapy. No exclusion of patients with previous cardiovascular toxicity Exclusion Criteria: No exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Patient under study condition<br>Patient under study condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE | Risk of cardiovascular toxicity by antitumoral agents is multifactorial. Clinical heart failure Asymptomatic ventricular dysfunction Elevated biomarkers Severe arrhythmias Myocardial ischemia Other cardiac events | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| change in EARLY DETECTION OF CARDIOTOXICITY | Early recognition of cardiotoxicity can help determine whether to continue treatment with a particular type of drug and set up preventive treatments. Demographic variables for study inclusion Clinical symptoms of cardiac disease EKG Transthoracic echocardiogram Biological markers: Troponin I (cTnI), NTproBNP Oncological variables: Diagnosis and cancer location, Drugs | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular toxicity in its different forms | Cardiotoxicity severity: Mild: asymptomatic, no hospitalization needed Severe: requires admission or specific treatment initiated for this reason | 2 years | 
| Incidence of cardiovascular toxicity in relation to the cumulative dose | Heart failure Asymptomatic ventricular dysfunction Myocardial Ischemia Severe arrhythmias Other cardiac pathology | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| •Incidence of cardiovascular toxicity in relation to the kind of antitumor agent | Heart failure Asymptomatic ventricular dysfunction Myocardial Ischemia Severe arrhythmias Other cardiac pathology | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| •Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters | - EKG | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters | Troponin I NT-proBNP | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| Compare the effectiveness of early identification of cardiovascular toxicity of high-sensitivity troponin (troponin T) compared to a conventional troponin | Troponin I (cTn I) Troponin Thigh sensitivity (cTnhs) | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| Define the sensitivity and specificity of the left ventricle ejection fraction in the detection of cardiovascular toxicity | Telediastolic volume left ventricle Telesystolic volume right ventricle Ejection fraction left ventricle Size of left atrium Size right atrium Mitral valve disease Tricuspid valve disease Pericardial overflow | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| • Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening. | - Longitudinal global strain | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years | 
| Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography. | Economic analysis comparing efficacy of biomarkers versus echocardiography | 2 years |