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Recruiting NCT06664528

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

— Observational Cardiac Toxicity Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECHOCARDIOGRAPHY, ELECTROCARDIOGRAPHY (ECG), LABORATORY TESTS.
Who it may be relevant to
Registry conditions: Cardiac Toxicity, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, exposed to potentially-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 of patients more likely to develop distant major adverse cardiovascular events (MACE). * Evaluate the usefulness of clinical, bio-humoral 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 recommendations of the available guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.

Interventions

  • Diagnostic test ECHOCARDIOGRAPHY
    A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
  • Diagnostic test ELECTROCARDIOGRAPHY (ECG)
    An ECG tracing will be obtained during each cardio-oncologic evaluation.
  • Diagnostic test LABORATORY 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.

Primary outcome measures

  • Incidence of cardiotoxicity [Time frame: 24 months]
  • Identification of major cardiovascular adverse events (MACE) [Time frame: 24 months]
Secondary outcome measures (1)
  • Identification of early predictors of cardiotoxicity [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non in — Rome

Identifiers

NCT: NCT06664528 · 6977

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗