Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, treated with cardiotoxic therapies.
The main purposes of the study are the following:
* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs. * Identify any subgroups more likely to develop distant major adverse cardiovascular events (MACE). * Evaluate the usefulness of clinical, biohumoral and echocardiographic parameters for early diagnosis of cardiotoxicity.
Participants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendation of the current guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over the age of 18 at the time of evaluation
Patients treated with potentially cardiotoxic anticancer drugs
Patients for which complete clinical, electrocardiographic and echocardiographic data are available at first evaluation and at least at one follow-up visit.
Disqualifiers
Patients under the age of 18 at the time of evaluation
Patients whose documentation of the first visit is not available
Patients for whom it is not possible to obtain follow-up information through a medical visit or by telephone
Patient with poor acoustic window for echocardiographic examination.
Trial population
Adult patients with cancer treated with potentially cardiotoxic anticancer drugs, with complete clinical, laboratory, electrocardiographic and echocardiographic data obtained at the first cardio-oncologic evaluation and at least at one follow-up visit.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ECHOCARDIOGRAPHY
Diagnostic testA complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
ELECTROCARDIOGRAPHY (ECG)
Diagnostic testAn ECG tracing will be obtained during each cardio-oncologic evaluation.
LABORATORY TESTS
Diagnostic testThe cardiac biomarkers high-sensitivity troponin I and N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be dosed according to the current recommendations of Cardio-Oncology Guidelines.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of cardiotoxicity
Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022.
Time frame
24 months2
Identification of major cardiovascular adverse events (MACE)
Identification of cardiovascular death, non-cardiovascular death and hospitalization for cardiac causes (congestive heart failure, major arrhythmias) both during the antineoplastic treatments and in the long-survivors population.
Time frame
24 monthsSecondary outcomes
1
Identification of early predictors of cardiotoxicity
Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov