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

Cardiovascular Toxicity Induced by Antitumoral Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02039622
• Other study ID #: GECAME-2010-01
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2014
• Last updated: January 15, 2014
• Start date: July 2011

Study information

• Verified date: January 2014
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: José Luis López-Sendón
• Phone: +34 639148765
• Email: jlopezsendon[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: 'Agencia Española de Medicamentos y Productos Sanitarios'
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3400
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Cardiovascular Toxicity Induced by Antitumoral Drugs

Locations

Country	Name	City	State
Spain	La pAz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE	Risk of cardiovascular toxicity by antitumoral agents is multifactorial.; Clinical heart failure; Asymptomatic ventricular dysfunction; Elevated biomarkers; Severe arrhythmias; Myocardial ischemia; Other cardiac events	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Primary	change in EARLY DETECTION OF CARDIOTOXICITY	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	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	Incidence of cardiovascular toxicity in its different forms	Cardiotoxicity severity: Mild: asymptomatic, no hospitalization needed; Severe: requires admission or specific treatment initiated for this reason	2 years	No
Secondary	Incidence of cardiovascular toxicity in relation to the cumulative dose	Heart failure; Asymptomatic ventricular dysfunction; Myocardial Ischemia; Severe arrhythmias; Other cardiac pathology	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	•Incidence of cardiovascular toxicity in relation to the kind of antitumor agent	Heart failure; Asymptomatic ventricular dysfunction; Myocardial Ischemia; Severe arrhythmias; Other cardiac pathology	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	•Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters	- EKG	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters	Troponin I; NT-proBNP	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	Compare the effectiveness of early identification of cardiovascular toxicity of high-sensitivity troponin (troponin T) compared to a conventional troponin	Troponin I (cTn I); Troponin Thigh sensitivity (cTnhs)	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	Define the sensitivity and specificity of the left ventricle ejection fraction in the detection of cardiovascular toxicity	Telediastolic volume left ventricle; Telesystolic volume right ventricle; Ejection fraction left ventricle; Size of left atrium; Size right atrium; Mitral valve disease; Tricuspid valve disease; Pericardial overflow	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	• Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening.	- Longitudinal global strain	21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years	No
Secondary	Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography.	Economic analysis comparing efficacy of biomarkers versus echocardiography	2 years	No

External Links

•   Web site of the study