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

Instituto de Investigación Hospital Universitario La Paz

Status

Unknown

Conditions

Cardiovascular Toxicity Induced by Antitumoral Drugs

Study type

Observational

Funder types

Other

Identifiers

NCT02039622

GECAME-2010-01

Details and patient eligibility

About

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

Full 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

Enrollment

3,400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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