Arrhythmogenic Right Ventricular DysplasiaLI-ARVCNCT05209776
Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy
A study testing Peripheral immunological assessment on venous blood and Immunological assessment carried out on intracardiac material in people with Arrhythmogenic Right Ventricular Dysplasia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. The present study aim to document the feasibility of detecting the potential presence of intracardiac local inflammatory components in patients with ARVC. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arrhythmogenic Right Ventricular Dysplasia
- What is being tested?
- Peripheral immunological assessment on venous blood and Immunological assessment carried out on intracardiac material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to Feb 2027
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For cases:
- Arrhythmogenic right ventricular dysplasia diagnosed (according to 2010 Task Force Criteria)
- Admitted for right ventricle electrophysiologic mapping
- For controls * Admitted for ablation procedures (accessory pathway, atrial flutter) on otherwise healthy hearts.
Who cannot join
- Diagnostic of systemic chronic inflammatory disease
- Presence of possible or proven cardiac involvement of an inflammatory disease, an acute or chronic infectious disease.
- Taking immunosuppressant or immunomodulating medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maxime BENEYTO contact
France1 site, 1 recruiting
- Recruiting
Toulouse University Hospital Center
Toulouse
Audrey TOMASIK, 5 61 77 85 97 ext. +33, tomasik.a@chu-toulouse.fr
Philippe MAURY
About this study
The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. The present study aim to document the feasibility of detecting the potential presence of intracardiac local inflammatory components in patients with ARVC.
Read the detailed description
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heritable condition characterized by right ventricular (RV) dilatation/dysfunction and malignant ventricular arrhythmias. The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. First, presence of subepicardial late gadolinium enhancement sharing the same characteristics as the ones found in myocarditis is common on cardiac magnetic resonance imaging (CMR). Second, clinical pathology findings of inflammatory infiltrates of mononuclear cells are frequent and correlate to the extent and severity of ARVC. Finally, from a biological standpoint, the exploratory study conducted by Campian et al. has shown an exaggerated humoral inflammatory response in peripheral blood whilst anti-desmoglein-2 antibodies (targeting a component of the desmosome) emerge as a sensitive and specific biomarker for ARVC. As specific treatments for ARVC are currently lacking, a better understanding of the humoral pathophysiology of the disease could unlock new therapeutic targets. We recently demonstrated that collecting local cardiomyocytes was feasible through irrigated ablation catheters in patients with ARVC. These steerable catheters may easily map the whole right ventricle and locate endocardial or epicardial scars. Aspiration of local blood or cellular material through the inner lumen of the catheter once pressed on the parietal wall may be an interesting technique for retrieving local inflammation markers.
- Being tested
- Peripheral immunological assessment on venous blood, Immunological assessment carried out on intracardiac material
- Keywords
- Cardiac Electrophysiologic Techniques, Inflammation, Cytokines, Interleukin-1, Interleukin-6, Interleukin-10, Transforming Growth Factor beta, Tumor Necrosis Factor-alpha
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia, Inflammation, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral immunological assessment on venous bloodBiological
Peripheral immunological assessment carried out as part of the research, on venous blood at the puncture point necessary for the electrophysiological examination: 1 heparin tube and 1 EDTA tube
Immunological assessment carried out on intracardiac materialBiological
Immunological assessment carried out as part of the research, on intracardiac material taken during the electrophysiological examination: 1 EDTA tube
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Carrier of a definite diagnosis of arrhythmogenic dysplasia of the right ventricle in line with the criteria of the Task Force 2010 (see Appendices), admitted for an electrical mapping of the right ventricle Receives: Biological: Peripheral immunological assessment on venous blood; Biological: Immunological assessment carried out on intracardiac material |
| Control case | Experimental | Without heart disease, admitted for a Kent bundle ablation or endocavity procedure / Wolff-Parkinson-White syndrome or common flutter (in subjects in whom the same irrigated material will be used and for whom echocardiography will have excluded associated heart disease). Receives: Biological: Peripheral immunological assessment on venous blood; Biological: Immunological assessment carried out on intracardiac material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the inflammatory components by C-reactive protein
Rate of C-reactive protein in the blood
Measured: 24 months
Identify the inflammatory components by interleukine1
Rate of interleukin 1 beta in the blood
Measured: 24 months
Identify the inflammatory components by onterleukine6
Rate of interleukin 6 in the blood
Measured: 24 months
Identify the inflammatory components by interleukine10
Rate of interleukin 10 in the blood
Measured: 24 months
Identify the inflammatory components by Tumor Necrosis Factor
Rate of Tumor Necrosis Factor alpha in the blood
Measured: 24 months
Identify the inflammatory components by Transforming Growth Factor
Rate of Transforming Growth Factor beta in the blood
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 posted27 Jan 2022
- Study start1 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic Right Ventricular DysplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MAURY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209776
- Sponsor's protocol ID
- RC31/21/0026
- Acronym
- LI-ARVC
- Status last verified
- May 2026
- First submitted
- 12 Jan 2022
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05209776
- Acronym / sponsor ID
- LI-ARVC / RC31/21/0026
- Keywords
- Cardiac Electrophysiologic Techniques, Inflammation, Cytokines, Interleukin-1, Interleukin-6, Interleukin-10, Transforming Growth Factor beta, Tumor Necrosis Factor-alpha
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Jan 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.
The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. The present study aim to document the feasibility of detecting the potential presence of intracardiac local inflammatory components in patients with ARVC.
Detailed description
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heritable condition characterized by right ventricular (RV) dilatation/dysfunction and malignant ventricular arrhythmias. The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. First, presence of subepicardial late gadolinium enhancement sharing the same characteristics as the ones found in myocarditis is common on cardiac magnetic resonance imaging (CMR). Second, clinical pathology findings of inflammatory infiltrates of mononuclear cells are frequent and correlate to the extent and severity of ARVC. Finally, from a biological standpoint, the exploratory study conducted by Campian et al. has shown an exaggerated humoral inflammatory response in peripheral blood whilst anti-desmoglein-2 antibodies (targeting a component of the desmosome) emerge as a sensitive and specific biomarker for ARVC. As specific treatments for ARVC are currently lacking, a better understanding of the humoral pathophysiology of the disease could unlock new therapeutic targets. We recently demonstrated that collecting local cardiomyocytes was feasible through irrigated ablation catheters in patients with ARVC. These steerable catheters may easily map the whole right ventricle and locate endocardial or epicardial scars. Aspiration of local blood or cellular material through the inner lumen of the catheter once pressed on the parietal wall may be an interesting technique for retrieving local inflammation markers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Biological: Peripheral immunological assessment on venous blood, Biological: Immunological assessment carried out on intracardiac materialCarrier of a definite diagnosis of arrhythmogenic dysplasia of the right ventricle in line with the criteria of the Task Force 2010 (see Appendices), admitted for an electrical mapping of the right ventricle |
| Control case | Experimental | Biological: Peripheral immunological assessment on venous blood, Biological: Immunological assessment carried out on intracardiac materialWithout heart disease, admitted for a Kent bundle ablation or endocavity procedure / Wolff-Parkinson-White syndrome or common flutter (in subjects in whom the same irrigated material will be used and for whom echocardiography will have excluded associated heart disease). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For cases:
- For controls * Admitted for ablation procedures (accessory pathway, atrial flutter) on otherwise healthy hearts.
Key exclusion criteria (3 listed)
- Diagnostic of systemic chronic inflammatory disease
- Presence of possible or proven cardiac involvement of an inflammatory disease, an acute or chronic infectious disease.
- Taking immunosuppressant or immunomodulating medications
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 |
|---|---|---|
| Peripheral immunological assessment on venous bloodPeripheral immunological assessment carried out as part of the research, on venous blood at the puncture point necessary for the electrophysiological examination: 1 heparin tube and 1 EDTA tube | Biological | Control case, Patients |
| Immunological assessment carried out on intracardiac materialImmunological assessment carried out as part of the research, on intracardiac material taken during the electrophysiological examination: 1 EDTA tube | Biological | Control case, Patients |
Primary outcome
Identify the inflammatory components by C-reactive protein
Time frame: 24 months
Rate of C-reactive protein in the blood
Identify the inflammatory components by interleukine1
Time frame: 24 months
Rate of interleukin 1 beta in the blood
Identify the inflammatory components by onterleukine6
Time frame: 24 months
Rate of interleukin 6 in the blood
Identify the inflammatory components by interleukine10
Time frame: 24 months
Rate of interleukin 10 in the blood
Identify the inflammatory components by Tumor Necrosis Factor
Time frame: 24 months
Rate of Tumor Necrosis Factor alpha in the blood
Identify the inflammatory components by Transforming Growth Factor
Time frame: 24 months
Rate of Transforming Growth Factor beta in the blood
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 1 Jun 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.
Maxime BENEYTO contact
Philippe MAURY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral immunological assessment on venous blood and Immunological assessment carried out on intracardiac material in people with Arrhythmogenic Right Ventricular Dysplasia, run by University Hospital, Toulouse 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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 Philippe MAURY, MD (5 61 32 34 70 ext. +33, maury.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the inflammatory components by C-reactive protein (time frame: 24 months). The study lists 6 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 1 Jun 2026.