NCT05209776

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

January 12, 2022

Last Update Submit

October 28, 2024

Conditions

Arrhythmogenic Right Ventricular Dysplasia

Keywords

Cardiac Electrophysiologic TechniquesInflammationCytokinesInterleukin-1Interleukin-6Interleukin-10Transforming Growth Factor betaTumor Necrosis Factor-alpha

Outcome Measures

Primary Outcomes (6)

  • Identify the inflammatory components by C-reactive protein

    Rate of C-reactive protein in the blood

    24 months

  • Identify the inflammatory components by interleukine1

    Rate of interleukin 1 beta in the blood

    24 months

  • Identify the inflammatory components by onterleukine6

    Rate of interleukin 6 in the blood

    24 months

  • Identify the inflammatory components by interleukine10

    Rate of interleukin 10 in the blood

    24 months

  • Identify the inflammatory components by Tumor Necrosis Factor

    Rate of Tumor Necrosis Factor alpha in the blood

    24 months

  • Identify the inflammatory components by Transforming Growth Factor

    Rate of Transforming Growth Factor beta in the blood

    24 months

Study Arms (2)

Patients

EXPERIMENTAL

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 bloodBiological: Immunological assessment carried out on intracardiac material

Control case

EXPERIMENTAL

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 bloodBiological: Immunological assessment carried out on intracardiac material

Interventions

Peripheral immunological assessment on venous bloodBIOLOGICAL

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

Control casePatients
Immunological assessment carried out on intracardiac materialBIOLOGICAL

Immunological assessment carried out as part of the research, on intracardiac material taken during the electrophysiological examination: 1 EDTA tube

Control casePatients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital Center

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular DysplasiaInflammationCamurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesCardiomyopathiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, Inborn

Study Officials

  • Philippe MAURY, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe MAURY, MD

CONTACT

5 61 32 34 70maury.p@chu-toulouse.fr

Maxime BENEYTO

CONTACT

beneyto.m@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 27, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)