Cardiovascular Toxicity Induced by Antitumoral Drugs Clinical Trial
Official title:
Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
The study is multicenter, post-authorization, observational and ambispective
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
;
Observational Model: Cohort