Cardiac ToxicityCV_CANCERNCT06664528
Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies
An observational study of Cardiac Toxicity and Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Toxicity, Cancer
- What is being tested?
- ECHOCARDIOGRAPHY, ELECTROCARDIOGRAPHY (ECG) and LABORATORY TESTS
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2025to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva
Rome, Lazio, 00168
Antonella Lombardo, +390630157070, antonella.lombardo@policlinicogemelli.it
Massimiliano Camilli, massimiliano.camilli.91@gmail.com
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Being tested
- ECHOCARDIOGRAPHY, ELECTROCARDIOGRAPHY (ECG), LABORATORY TESTS
- Medical subject headings
- Cardiotoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHOCARDIOGRAPHYDiagnostic 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 TESTSDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (1)
Identification of early predictors of cardiotoxicity
Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start28 Feb 2025
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella Lombardo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664528
- Sponsor's protocol ID
- 6977
- Acronym
- CV_CANCER
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study
- ClinicalTrials.gov ID
- NCT06664528
- Acronym / sponsor ID
- CV_CANCER / 6977
- Conditions
- Cardiac Toxicity, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOCARDIOGRAPHYA 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 TESTSThe 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. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Identification of early predictors of cardiotoxicity
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Related trials for Cardiac Toxicity
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 3
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
Aluminum Phosphide Poisoning
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonella Lombardo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Toxicity and Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella Lombardo (+390630157070, antonella.lombardo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiotoxicity (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.