Clinical trial NCT05024708: Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Official title: Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy
Keywords: ARVC, Athlete's heart, exercise, CMR, RV contractile reserve
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
timeFrame: Through study completion, an average of 1 month
measure: Evolution of S' tricuspid wave during exercise
timeFrame: Through study completion, an average of 1 month
measure: Evolution of RV fractional area during exercise
timeFrame: Through study completion, an average of 1 month
measure: Evolution of free wall RV strain during exercise
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: