Arrhythmogenic CardiomyopathiesCharACTPET-MRNCT05450783
Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy
An observational study of Arrhythmogenic Cardiomyopathies, run by Nantes University Hospital at 5 sites in France.
Trial summary
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and… Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Arrhythmogenic Cardiomyopathies
- What is being tested?
- Biocollection
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Sep 2022to 31 Dec 2026
- How long will I take part?
- 18 Months
- 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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20
Who may be able to join
- Male and female over 16 years old
Who cannot join
- Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 Consent form
- Sarcoidosis or known or diagnosed autoimmune disease
- History of myocardial infarction
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Angers
Angers, 49000
Loïc BIERE, PH, loic.biere@chu-angers.fr
- Recruiting
CHU Brest
Brest, 29000
Ronan ABGRAL, PH, ronan.abgral@chu-brest.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Nicolas Piriou, PH, 0253482781, nicolas.piriou@chu-nantes.fr
Aurélie Thollet, 0240165279, aurelie.thollet@chu-nantes.fr
- Recruiting
AP-HP La Salpêtrière
Paris, 75013
Estelle GANDJBAKHCH, PH, estelle.gandjbakhch@aphp.fr
- Recruiting
CHU de Rennes
Rennes, 35000
Erwan Donal, PU-PH, erwan.donal@chu-rennes.fr
About this study
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.
Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).
Read more
Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.
Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.
Read the detailed description
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.
Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).
Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.
Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.
- Conditions
- Arrhythmogenic Cardiomyopathies
- Being tested
- Biocollection
- Keywords
- Arrhythmogenic cardiomyopathies, PET-MR imaging, Myocardial inflammation, Prognosis, Cardiac auto-antibodies
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiocollectionOther
serum
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Patients and their relatives affected with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 Receives: Other: Biocollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-RMI patients profile
Rate of patients observed in the different expected PET-MRI patterns in the left ventricle (no late enhancement and no PET fixation, late enhancement and no PET fixation, concordant late enhancement and PET fixation, discordant late enhancement and PET fixation).
Measured: one hour
Secondary outcomes (4)
PET-RMI patterns in the right ventricle
Rate of patients with different expected PET-MRI patterns in the right ventricle (no late enhancement and no PET fixation, late enhancement and no PET fixation, concordant late enhancement and PET fixation, discordant late enhancement and PET fixation)
Measured: one hour
Prognosis according to PET-RMI patterns
Comparison of event rates (death, heart transplantation, resuscitated sudden death, hemodynamically unstable VT, syncopal VT, hospitalization for heart failure, myocarditis) observed during follow-up according to the different expected LV and RV PET-MRI profiles observed at inclusion
Measured: 15-32 months
Cardiac auto-antibodies according to PET-RMI patterns
Comparison of the rates of patients with circulating cardiac autoantibodies detected by indirect immunofluorescence technique according to the different expected LV and RV PET-MRI profiles at inclusion
Measured: one hour
Spatial concordance
Rate of spatial concordance of segments with late enhancement and PET fixation on bulls-eye representations according to AHA segmentation
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 80 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest, University Hospital, Paris, University Hospital, Angers
- Responsible party
- Sponsor
- Investigators
- Nicolas Piriou, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450783
- Sponsor's protocol ID
- RC22_0010
- Acronym
- CharACTPET-MR
- Status last verified
- Apr 2026
- First submitted
- 16 May 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05450783
- Acronym / sponsor ID
- CharACTPET-MR / RC22_0010
- Conditions
- Arrhythmogenic Cardiomyopathies
- Keywords
- Arrhythmogenic cardiomyopathies, PET-MR imaging, Myocardial inflammation, Prognosis, Cardiac auto-antibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Brest, University Hospital, Paris, University Hospital, Angers
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 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.
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.
Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).
Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.
Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.
Detailed description
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.
Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).
Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.
Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: BiocollectionPatients and their relatives affected with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20
Key inclusion criteria (1 listed)
- Male and female over 16 years old
Key exclusion criteria (4 listed)
- Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 Consent form
- Sarcoidosis or known or diagnosed autoimmune disease
- History of myocardial infarction
- Patient under guardianship, curatorship or safeguard of justice
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 |
|---|---|---|
| Biocollectionserum | Other | Patients group |
Primary outcome
PET-RMI patients profile
Time frame: one hour
Rate of patients observed in the different expected PET-MRI patterns in the left ventricle (no late enhancement and no PET fixation, late enhancement and no PET fixation, concordant late enhancement and PET fixation, discordant late enhancement and PET fixation).
4 secondary outcomes
PET-RMI patterns in the right ventricle
Time frame: one hour
Prognosis according to PET-RMI patterns
Time frame: 15-32 months
Cardiac auto-antibodies according to PET-RMI patterns
Time frame: one hour
Spatial concordance
Time frame: one hour
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Nicolas Piriou, PH principal investigator
Nantes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmogenic Cardiomyopathies, run by Nantes University Hospital at 5 sites 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 1 inclusion and 4 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Nicolas Piriou, PH (0253482781, nicolas.piriou@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-RMI patients profile (time frame: one hour). 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 17 Apr 2026.