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Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05209776
Acronym
LI-ARVC
Enrollment
80
Registered
2022-01-27
Start date
2022-02-01
Completion date
2027-02-01
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia

Keywords

Cardiac Electrophysiologic Techniques, Inflammation, Cytokines, Interleukin-1, Interleukin-6, Interleukin-10, Transforming Growth Factor beta, Tumor Necrosis Factor-alpha

Brief 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.

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

BIOLOGICALPeripheral 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

BIOLOGICALImmunological 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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identify the inflammatory components by C-reactive protein24 monthsRate of C-reactive protein in the blood
Identify the inflammatory components by interleukine124 monthsRate of interleukin 1 beta in the blood
Identify the inflammatory components by onterleukine624 monthsRate of interleukin 6 in the blood
Identify the inflammatory components by interleukine1024 monthsRate of interleukin 10 in the blood
Identify the inflammatory components by Tumor Necrosis Factor24 monthsRate of Tumor Necrosis Factor alpha in the blood
Identify the inflammatory components by Transforming Growth Factor24 monthsRate of Transforming Growth Factor beta in the blood

Countries

France

Contacts

CONTACTPhilippe MAURY, MD
maury.p@chu-toulouse.fr5 61 32 34 70
CONTACTMaxime BENEYTO
beneyto.m@chu-toulouse.fr
PRINCIPAL_INVESTIGATORPhilippe MAURY, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026