Arrhythmogenic CardiomyopathyACORENCT05569356
Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)
An observational study of Arrhythmogenic Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arrhythmogenic Cardiomyopathy
- What is being tested?
- Prospective and Retrospective
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2022to 20 Oct 2032
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with clinical or preclinical Arrhythmogenic Cardiomyopathy (carrier of risk mutation). The retrospective patients will be informed by mail and the prospective patients will be informed during their routine care visit, both using the opt-out approach.
Who may be able to join
- Adult patient (age ≥ 18 years old)
- Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force
- Patient carrying a pathogenic mutation responsible for cardiomyopathy
- Patient informed individually of the research
Who cannot join
- Patients under curatorship/guardianship
- Pregnant women
- Patients who expressed their opposition 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.
Mikael LAREDO, Dr contact
About this study
Official title: Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.
Read the detailed description
The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.
Many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.
The objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.
- Conditions
- Arrhythmogenic Cardiomyopathy
- Being tested
- Prospective, Retrospective
- Keywords
- Arrhythmogenic Cardiomyopathy, Inflammatory biomarkers, Autoantibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProspectiveBiological
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)
RetrospectiveOther
None (only data collection)
| Study group | Role | What they receive |
|---|---|---|
| Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective) | Not described Receives: Biological: Prospective | |
| Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective) | Not described Receives: Other: Retrospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC)
Measured: 10 years
Secondary outcomes (7)
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging
Measured: 10 years
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)
Measured: 10 years
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time
Measured: 10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain
Measured: 10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data
Measured: 10 years
Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR
Measured: 10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Oct 2032 (estimated)
- Study completion20 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle GANDJBAKHCH, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569356
- Sponsor's protocol ID
- APHP210985
- Other IDs
- 2022-A00283-40
- Acronym
- ACORE
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
- ClinicalTrials.gov ID
- NCT05569356
- Acronym / sponsor ID
- ACORE / APHP210985
- Conditions
- Arrhythmogenic Cardiomyopathy
- Keywords
- Arrhythmogenic Cardiomyopathy, Inflammatory biomarkers, Autoantibodies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Oct 2032 (estimated)
- Study completion
- 20 Oct 2032 (estimated)
- First posted
- 6 Oct 2022 (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 study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.
Detailed description
The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.
Many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.
The objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective) | – | Biological: Prospective |
| Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective) | – | Other: Retrospective |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with clinical or preclinical Arrhythmogenic Cardiomyopathy (carrier of risk mutation). The retrospective patients will be informed by mail and the prospective patients will be informed during their routine care visit, both using the opt-out approach.
Key inclusion criteria (4 listed)
- Adult patient (age ≥ 18 years old)
- Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force
- Patient carrying a pathogenic mutation responsible for cardiomyopathy
- Patient informed individually of the research
Key exclusion criteria (3 listed)
- Patients under curatorship/guardianship
- Pregnant women
- Patients who expressed their opposition 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 |
|---|---|---|
| Prospective-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care) | Biological | Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective) |
| RetrospectiveNone (only data collection) | Other | Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective) |
Primary outcome
Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC)
Time frame: 10 years
7 secondary outcomes
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging
Time frame: 10 years
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)
Time frame: 10 years
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time
Time frame: 10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain
Time frame: 10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data
Time frame: 10 years
Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR
Time frame: 10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.
Time frame: 10 years
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 13 Oct 2022.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Mikael LAREDO, Dr contact
Estelle GANDJBAKHCH, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
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 Arrhythmogenic Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Oct 2022. 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 France. 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 Estelle GANDJBAKHCH, Dr (+33 1 42 16 30 55, estelle.gandjbakhch@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC) (time frame: 10 years). 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 13 Oct 2022.