Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

NCT06664528 | Recruiting

• 1 other identifier: 6977
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Toxicity; Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of cardiotoxicity

  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)

  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 Outcomes (1)

• Identification of early predictors of cardiotoxicity

  24 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms

Interventions

Echocardiography; Electrocardiography; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Investigative Techniques

Study Officials

• Antonella Lombardo

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Lombardo

CONTACT

+390630157070; antonella.lombardo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: March 4, 2025

Record last verified: 2024-10

Locations

IT (1)