Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies (CV_CANCER)

February 28, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Antonella Lombardo
Phone Number: +390630157070
Email: antonella.lombardo@policlinicogemelli.it

Study Locations

Italy
- Lazio
  - Roma, Lazio, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva
    - Contact:
      
      Antonella Lombardo
      
      Phone Number: +390630157070
      
      Email: antonella.lombardo@policlinicogemelli.it
    - Contact:
      
      Massimiliano Camilli
      
      Email: massimiliano.camilli.91@gmail.com
    - Principal Investigator:
      
      Antonella Lombardo
    - Sub-Investigator:
      
      Massimiliano Camilli
    - Sub-Investigator:
      
      Priscilla Lamendola
    - Sub-Investigator:
      
      Marcello Viscovo
    - Sub-Investigator:
      
      Stefan Hohaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Antonella Lombardo, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Estimated)

November 15, 2028

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria