NCT02039622

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,400 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is multicenter, post-authorization, observational and ambispective

Detailed description

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

Conditions

• Cardiovascular Toxicity Induced by Antitumoral Drugs

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-12-01
• First posted: 2014-01-17
• Last updated: 2014-01-17

Locations

1 site across 1 country: Spain