Current partner codePEPTIDESDE
NCT06664528·Not applicable·OBSERVATIONAL

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

Status

Recruiting

Phase

Not applicable

Enrollment

300

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Oct 29, 2024

  2. Study start

    Feb 28, 2025

  3. Primary completion

    Nov 15, 2028

  4. Study completion

    Dec 15, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 4, 2025

Outcomes

What the study measures.

Primary outcomes

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.

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.

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

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

Rome, Lazio, Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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