Clinical trial NCT06664528: Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies
Official title: Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Toxicity
Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cardiotoxicity
timeFrame: 24 months
measure: Identification of major cardiovascular adverse events (MACE)
timeFrame: 24 months
Secondary outcomes:
measure: Identification of early predictors of cardiotoxicity
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Antonella Lombardo
role: PRINCIPAL_INVESTIGATOR
References: