LI-ARVC: Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT05209776

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmogenic Right Ventricular Dysplasia	Biological: Peripheral immunological assessment on venous blood Biological: Immunological assessment carried out on intracardiac material	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients 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	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
Experimental: Control case 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).	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

Arm

Intervention/Treatment

Experimental: Patients

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

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

Experimental: Control case

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).

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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