Cardiovascular Toxicity Induced by Antitumoral DrugsNCT02039622
Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
An observational study of Cardiovascular Toxicity Induced by Antitumoral Drugs, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The study is multicenter, post-authorization, observational and ambispective Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Toxicity Induced by Antitumoral Drugs
- How many people
- 3,400 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Dec 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La pAz University Hospital
Madrid, Madrid, 28046
Jose Luis Lopez-Sendon, +34 639148765, jlopezsendon@gmail.com
Maria Torrent, (+34) 607684323, maria.torrente@idipaz.es
About this study
The study is multicenter, post-authorization, observational and ambispective
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient under study condition | Patient under study condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
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
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Secondary outcomes (9)
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
Measured: 2 years
Incidence of cardiovascular toxicity in relation to the cumulative dose
- Heart failure
- Asymptomatic ventricular dysfunction
- Myocardial Ischemia
- Severe arrhythmias
- Other cardiac pathology
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Incidence of cardiovascular toxicity in relation to the kind of antitumor agent
- Heart failure
- Asymptomatic ventricular dysfunction
- Myocardial Ischemia
- Severe arrhythmias
- Other cardiac pathology
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters
- EKG
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters
- Troponin I
- NT-proBNP
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
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)
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
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
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
• Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening.
- Longitudinal global strain
Measured: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography.
Economic analysis comparing efficacy of biomarkers versus echocardiography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Toxicity Induced by Antitumoral DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 3,400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Luis Lopez-Sendon, Principal investigator, La Paz University Hospital- Chief of Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039622
- Sponsor's protocol ID
- GECAME-2010-01
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33624069
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
- ClinicalTrials.gov ID
- NCT02039622
- Acronym / sponsor ID
- GECAME-2010-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient under study condition | – | –Patient under study condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Risk of cardiovascular toxicity by antitumoral agents is multifactorial. * Clinical heart failure * Asymptomatic ventricular dysfunction * Elevated biomarkers * Severe arrhythmias * Myocardial ischemia * Other cardiac events
change in EARLY DETECTION OF CARDIOTOXICITY
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
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
9 secondary outcomes
Incidence of cardiovascular toxicity in its different forms
Time frame: 2 years
Incidence of cardiovascular toxicity in relation to the cumulative dose
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Incidence of cardiovascular toxicity in relation to the kind of antitumor agent
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Compare the effectiveness of early identification of cardiovascular toxicity of high-sensitivity troponin (troponin T) compared to a conventional troponin
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Define the sensitivity and specificity of the left ventricle ejection fraction in the detection of cardiovascular toxicity
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
• Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening.
Time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Derived from this study: PubMed 33624069Caro-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.
- Web site of the studyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Lopez-Sendon principal investigator
La Paz University Hospital- Chief of Cardiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Toxicity Induced by Antitumoral Drugs, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Luis López-Sendón (+34 639148765, jlopezsendon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE (time frame: 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.