Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peripheral immunological assessment on venous blood, Immunological assessment carried out on intracardiac material.
- Who it may be relevant to
- Registry conditions: Arrhythmogenic Right Ventricular Dysplasia. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Peripheral immunological assessment on venous blood
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 - Biological Immunological assessment carried out on intracardiac material
Immunological assessment carried out as part of the research, on intracardiac material taken during the electrophysiological examination: 1 EDTA tube
Primary outcome measures
- Identify the inflammatory components by C-reactive protein [Time frame: 24 months]
- Identify the inflammatory components by interleukine1 [Time frame: 24 months]
- Identify the inflammatory components by onterleukine6 [Time frame: 24 months]
- Identify the inflammatory components by interleukine10 [Time frame: 24 months]
- Identify the inflammatory components by Tumor Necrosis Factor [Time frame: 24 months]
- Identify the inflammatory components by Transforming Growth Factor [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Toulouse University Hospital Center — Toulouse
Identifiers
NCT: NCT05209776 · RC31/21/0026