Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE
研究概览
简要总结
The study is multicenter, post-authorization, observational and ambispective
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No exclusion criteria.
结局指标
主要结局
Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE
时间窗: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Risk of cardiovascular toxicity by antitumoral agents is multifactorial. * Clinical heart failure * Asymptomatic ventricular dysfunction * Elevated biomarkers * Severe arrhythmias * Myocardial ischemia * Other cardiac events
change in EARLY DETECTION OF CARDIOTOXICITY
时间窗: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
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
次要结局
- • Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening.(21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years)
- Incidence of cardiovascular toxicity in relation to the cumulative dose(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(21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years)
- Incidence of cardiovascular toxicity in its different forms(2 years)
- Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography.(2 years)
- •Incidence of cardiovascular toxicity in relation to the kind of antitumor agent(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(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(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(21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years)