RecruitingNCT06664528

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

300 participants

Start Date

Feb 28, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria5

  • 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.
  • Refusal of informed consent to participate in the study.

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Interventions

DIAGNOSTIC_TESTECHOCARDIOGRAPHY

A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.

DIAGNOSTIC_TESTELECTROCARDIOGRAPHY (ECG)

An ECG tracing will be obtained during each cardio-oncologic evaluation.

DIAGNOSTIC_TESTLABORATORY TESTS

The 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.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva

Rome, Lazio, Italy

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NCT06664528


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