Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)

Not Applicable

Recruiting

• Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy
• Interventions: Other: Cardiac exercises and tests

• Registration Number: NCT05024708
• Lead Sponsor: Rennes University Hospital

Brief Summary

Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological remodeling of the RV; ie. arrhythmogenic right ventricular cardiomyopathy (ARVC) and athlete's heart.

Detailed Description

Comparison of the RV contractile reserve in 4 groups of patients: Arrhythmogenic right ventricular cardiomyopathy (ARVC) patients; endurance athletes with a dilated RV, endurance athletes with normal RV, untrained subject with normal RV.

Patients will come to the hospital for 3 visits (3 half days):

* Visit 1: clinical evaluation, rest ECG, rest echocardiography, cardio-pulmonary exercise test.

* Visit 2: exercise echocardiography, holter ECG monitor (48 yours)

* Visit 3: rest CMR and exercise CMR (ergocycle)

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Study Start: 2023-01-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-01-16
• Study Completion: 2024-01-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Men or women aged 18 years and older,

  • patients with confirmed ARVC, but with no major RV dysfunction (RVEF >40%)
  • endurance athletes with dilated RV
  • endurance athletes with non-dilated RV
  • untrained healthy subjects with non-dilated RV

• who signed a written free and informed consent:

Exclusion Criteria

• Patients with other cardiovascular disease;
• Contra-indication to CMR (in particular presence of a non-CMR compatible implantable cardiac defibrillator);
• Patients with permanent supraventricular arrhythmia;
• Patients unable to perform an exercise test on an ergocycle;
• Person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endurance athletes with a dilated RV	Cardiac exercises and tests	-
Untrained subject with normal RV	Cardiac exercises and tests	-
ARVC patients	Cardiac exercises and tests	-
Endurance athletes with normal RV	Cardiac exercises and tests	-

Primary Outcome Measures

Name	Time	Method
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise	Through study completion, an average of 1 month

Secondary Outcome Measures

Name	Time	Method
Evolution of S' tricuspid wave during exercise	Through study completion, an average of 1 month
Evolution of free wall RV strain during exercise	Through study completion, an average of 1 month
Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise	Through study completion, an average of 1 month
Evolution of RV fractional area during exercise	Through study completion, an average of 1 month

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France