NCT05450783

Brief Summary

Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation. Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis). Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data. Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

May 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

May 16, 2022

Last Update Submit

April 14, 2026

Conditions

Arrhythmogenic Cardiomyopathies

Keywords

Arrhythmogenic cardiomyopathiesPET-MR imagingMyocardial inflammationPrognosisCardiac auto-antibodies

Outcome Measures

Primary Outcomes (1)

  • PET-RMI patients profile

    Rate of patients observed in the different expected PET-MRI patterns in the left ventricle (no late enhancement and no PET fixation, late enhancement and no PET fixation, concordant late enhancement and PET fixation, discordant late enhancement and PET fixation).

    one hour

Secondary Outcomes (4)

  • PET-RMI patterns in the right ventricle

    one hour

  • Prognosis according to PET-RMI patterns

    15-32 months

  • Cardiac auto-antibodies according to PET-RMI patterns

    one hour

  • Spatial concordance

    one hour

Study Arms (1)

Patients group

Patients and their relatives affected with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20

Other: Biocollection

Interventions

BiocollectionOTHER

serum

Patients group

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20

You may qualify if:

  • Male and female over 16 years old

You may not qualify if:

  • Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 Consent form
  • Sarcoidosis or known or diagnosed autoimmune disease
  • History of myocardial infarction
  • Patient under guardianship, curatorship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Angers

Angers, 49000, France

RECRUITING

CHU Brest

Brest, 29000, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

AP-HP La Salpêtrière

Paris, 75013, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Nicolas Piriou, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Piriou, PH

CONTACT

0253482781nicolas.piriou@chu-nantes.fr

Aurélie Thollet

CONTACT

0240165279aurelie.thollet@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

July 11, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)