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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05209776
Other study ID # RC31/21/0026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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