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

Brief Title

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)

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 Type

Interventional


Primary Outcome

Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise

Secondary Outcome

 Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise

Condition

Arrhythmogenic Right Ventricular Cardiomyopathy

Intervention

Cardiac exercises and tests

Study Arms / Comparison Groups

 ARVC patients
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

November 1, 2021

Completion Date

December 1, 2022

Primary Completion Date

November 1, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +33 2.99.28.41.33, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05024708

Organization ID

35RC21_9886_CA2VD


Responsible Party

Sponsor

Study Sponsor

Rennes University Hospital


Study Sponsor

, , 


Verification Date

August 2021