Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

NCT ID: NCT06664528

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-12-15

Brief Summary

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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

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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.

Conditions

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Cardiac Toxicity Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ECHOCARDIOGRAPHY

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

Intervention Type DIAGNOSTIC_TEST

ELECTROCARDIOGRAPHY (ECG)

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonella Lombardo

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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

Rome, Lazio, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonella Lombardo

Role: CONTACT

+390630157070

Facility Contacts

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Antonella Lombardo

Role: primary

+390630157070

Massimiliano Camilli

Role: backup

Other Identifiers

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6977

Identifier Type: -

Identifier Source: org_study_id

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