Cardiomyopathy Due to DrugNCT06331806
Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity
A study testing Evaluation of myocardial fibrosis in people with Cardiomyopathy Due to Drug, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy Due to Drug
- What is being tested?
- Evaluation of myocardial fibrosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.
Who cannot join
- Age <18 years
- Contraindications to contrast medium magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Daniela Cardinale, MD, daniela.cardinale@ieo.it
About this study
Official title: Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications
This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment
Read the detailed description
The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.
Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) >10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.
All patients will undergo:
- at time 0
- an echocardiogram with LVEF evaluation (biplane method)
- a single blood sample.
- at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).
- Conditions
- Cardiomyopathy Due to Drug
- Being tested
- Evaluation of myocardial fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of myocardial fibrosisDiagnostic test
echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of myocardial fibrosis | Other | Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent Receives: Diagnostic Test: Evaluation of myocardial fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
Measured: 1 month
Evaluation of blood levels of Galectin-3 (Gal-3)
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
Measured: 1 month
Evaluation of Enhanced Liver Fibrosis score (ELF)
Evaluation of Enhanced Liver Fibrosis score (ELF) as biomarker of fibrosis ELF score is a "marker set" constituted by 3 markers of fibrosis: lhyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of metalloproteinase 1, firstly utilized in the diagnosis and assessment of the severity of liver
Measured: 1 month
Evaluation of CMR imaging marker of fibrosis
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
Measured: 1 month
Secondary outcomes (3)
Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
evaluation of the response to heart failure treatment in terms of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
Measured: 1 month
Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)
Troponin I (TnI) and B-type Natriuretic Peptide (BNP) are biomarkers already utilized in the early diagnosis and monitoring of AIC and recognized prognostic indexes in patients with heart failure.
Measured: 1 month
Evaluation of levels of cytochrome C
cytochrome C is a marker of mitochondrial dysfunction
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 Feb 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy Due to DrugStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Cardinale, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331806
- Sponsor's protocol ID
- IEO 398
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications
- ClinicalTrials.gov ID
- NCT06331806
- Acronym / sponsor ID
- IEO 398
- Conditions
- Cardiomyopathy Due to Drug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 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.
This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment
Detailed description
The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.
Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) >10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.
All patients will undergo:
- at time 0
- an echocardiogram with LVEF evaluation (biplane method)
- a single blood sample.
- at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of myocardial fibrosis | Other | Diagnostic Test: Evaluation of myocardial fibrosisEchocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.
Key exclusion criteria (2 listed)
- Age <18 years
- Contraindications to contrast medium magnetic resonance imaging
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 |
|---|---|---|
| Evaluation of myocardial fibrosisechocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent | Diagnostic test | Evaluation of myocardial fibrosis |
Primary outcome
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
Time frame: 1 month
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
Evaluation of blood levels of Galectin-3 (Gal-3)
Time frame: 1 month
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
Evaluation of Enhanced Liver Fibrosis score (ELF)
Time frame: 1 month
Evaluation of Enhanced Liver Fibrosis score (ELF) as biomarker of fibrosis ELF score is a "marker set" constituted by 3 markers of fibrosis: lhyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of metalloproteinase 1, firstly utilized in the diagnosis and assessment of the severity of liver
Evaluation of CMR imaging marker of fibrosis
Time frame: 1 month
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
3 secondary outcomes
Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
Time frame: 1 month
Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)
Time frame: 1 month
Evaluation of levels of cytochrome C
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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. This study is not recruiting at the moment.
Daniela Cardinale, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of myocardial fibrosis in people with Cardiomyopathy Due to Drug, run by European Institute of Oncology 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Cardinale, MD (+39 0257489748, daniela.cardinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) (time frame: 1 month). The study lists 4 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 24 Jun 2024.