Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Arrhythmogenic Right Ventricular Dysplasia Clinical Trial

— LI-ARVC  

Official title:

Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209776
• Other study ID #: RC31/21/0026
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: Philippe MAURY, MD
• Phone: 5 61 32 34 70
• Email: maury.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Inflammation

Intervention

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
• 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

Locations

Country	Name	City	State
France	Toulouse University Hospital Center	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the inflammatory components by C-reactive protein	Rate of C-reactive protein in the blood	24 months
Primary	Identify the inflammatory components by interleukine1	Rate of interleukin 1 beta in the blood	24 months
Primary	Identify the inflammatory components by onterleukine6	Rate of interleukin 6 in the blood	24 months
Primary	Identify the inflammatory components by interleukine10	Rate of interleukin 10 in the blood	24 months
Primary	Identify the inflammatory components by Tumor Necrosis Factor	Rate of Tumor Necrosis Factor alpha in the blood	24 months
Primary	Identify the inflammatory components by Transforming Growth Factor	Rate of Transforming Growth Factor beta in the blood	24 months