Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Not Applicable

Recruiting

• Conditions: Arrhythmogenic Right Ventricular Dysplasia
• Interventions: Biological: Peripheral immunological assessment on venous blood; Biological: Immunological assessment carried out on intracardiac material

• Registration Number: NCT05209776
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2022-02-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control case	Peripheral immunological assessment on venous blood	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).
Patients	Peripheral immunological assessment on venous blood	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
Patients	Immunological assessment carried out on intracardiac material	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
Control case	Immunological assessment carried out on intracardiac material	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).

Primary Outcome Measures

Name	Time	Method
Identify the inflammatory components by interleukine1	24 months	Rate of interleukin 1 beta in the blood
Identify the inflammatory components by C-reactive protein	24 months	Rate of C-reactive protein in the blood
Identify the inflammatory components by interleukine10	24 months	Rate of interleukin 10 in the blood
Identify the inflammatory components by Transforming Growth Factor	24 months	Rate of Transforming Growth Factor beta in the blood
Identify the inflammatory components by onterleukine6	24 months	Rate of interleukin 6 in the blood
Identify the inflammatory components by Tumor Necrosis Factor	24 months	Rate of Tumor Necrosis Factor alpha in the blood

Trial Locations

Locations (1)

Toulouse University Hospital Center; 🇫🇷 Toulouse, France