NCT06664528

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiac Toxicity
• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2028-11-15
• Completion: 2028-12-15
• First posted: 2024-10-29
• Last updated: 2025-03-04

Locations

1 site across 1 country: Italy