Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ARVC patients
Intervention: Cardiac exercises and tests (Other)
Endurance athletes with a dilated RV
Intervention: Cardiac exercises and tests (Other)
Endurance athletes with normal RV
Intervention: Cardiac exercises and tests (Other)
Untrained subject with normal RV
Intervention: Cardiac exercises and tests (Other)
Outcomes
Primary Outcomes
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Time Frame: Through study completion, an average of 1 month
Secondary Outcomes
- 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)
- 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)