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NCT Number: NCT06664528

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Antonella Lombardo

CONTACT

[email protected]

+390630157070

Antonella Lombardo

PRINCIPAL_INVESTIGATOR

Marcello Viscovo

SUB_INVESTIGATOR

Massimiliano Camilli

CONTACT

[email protected]

Massimiliano Camilli

SUB_INVESTIGATOR

Priscilla Lamendola

SUB_INVESTIGATOR

Stefan Hohaus

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Diagnostic Test

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

Electrocardiography (ECG)

Diagnostic Test

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

Laboratory tests

Diagnostic Test

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 outcomes

  1. Incidence of cardiotoxicity

    Time frame: 24 months

    Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022.

  2. Identification of major cardiovascular adverse events (MACE)

    Time frame: 24 months

    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.

Secondary outcomes

  1. Identification of early predictors of cardiotoxicity

    Time frame: 24 months

    Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Lombardo

CONTACT

[email protected]

+390630157070

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: CV_CANCER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 29, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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