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

Arrhythmogenic Right Ventricular Cardiomyopathy Clinical Trial

— CA2VD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024708
• Other study ID #: 35RC21_9886_CA2VD
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: January 16, 2024

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: Frédéric SCHNELL, MD-PhD
• Phone: +33 2.99.28.41.33
• Email: Frederic.SCHNELL[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies

Intervention

Other:
• Cardiac exercises and tests
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise		Through study completion, an average of 1 month
Secondary	Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise		Through study completion, an average of 1 month
Secondary	Evolution of S' tricuspid wave during exercise		Through study completion, an average of 1 month
Secondary	Evolution of RV fractional area during exercise		Through study completion, an average of 1 month
Secondary	Evolution of free wall RV strain during exercise		Through study completion, an average of 1 month