Clinical trial NCT02039622: Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
Official title: Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Toxicity Induced by Antitumoral Drugs
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 3400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A case is defined as a patient on treatment (started or programmed, regardless of previous treatments or prior radiotherapy) with the following target antineoplastic agents:

* Alkylating agents
* Antimicrotubule agents
* Vinca alkaloids
* Monoclonal Antibodies
* Antimetabolites
* Anthracyclines
* Angiogenesis inhibitors
* Interleukins
* Small molecule tyrosine kinase inhibitors
* Other antineoplastic agents

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: change in EARLY DETECTION OF CARDIOTOXICITY
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Secondary outcomes:
measure: Incidence of cardiovascular toxicity in its different forms
timeFrame: 2 years
measure: Incidence of cardiovascular toxicity in relation to the cumulative dose
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: •Incidence of cardiovascular toxicity in relation to the kind of antitumor agent
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: •Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: Compare the effectiveness of early identification of cardiovascular toxicity of high-sensitivity troponin (troponin T) compared to a conventional troponin
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: Define the sensitivity and specificity of the left ventricle ejection fraction in the detection of cardiovascular toxicity
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: • Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening.
timeFrame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
measure: Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography.
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La pAz University Hospital
Study officials:
affiliation: La Paz University Hospital- Chief of Cardiology Department
name: Jose Luis Lopez-Sendon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caro-Codon J, Lopez-Fernandez T, Alvarez-Ortega C, Zamora Aunon P, Rodriguez IR, Gomez Prieto P, Buno Soto A, Canales Albendea M, Albaladejo A, Mediavilla G, Feliu Batlle J, Rodriguez Fraga O, Martinez Monzonis A, Gonzalez-Costello J, Serrano Antolin JM, Cadenas Chamorro R, Gonzalez-Juanatey JR, Lopez-Sendon J; CARDIOTOX registry investigators. Cardiovascular risk factors during cancer treatment. Prevalence and prognostic relevance: insights from the CARDIOTOX registry. Eur J Prev Cardiol. 2022 May 6;29(6):859-868. doi: 10.1093/eurjpc/zwaa034.